actiTENS mini
Device Facts
| Record ID | K252767 |
|---|---|
| Device Name | actiTENS mini |
| Applicant | Sublimed |
| Product Code | GZJ · Neurology |
| Decision Date | Jan 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Over-the-counter use : actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. Prescription use: actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Adjunctive treatment for post-surgical and post-trauma acute pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. Electrical Muscle Stimulation (EMS), used for the following indications: -Temporary relaxation of muscle spasms -Prevent or retard disuse atrophy -Increase of local blood flow in the treatment area -Re-educate muscles -Maintain or increase the range of motion -Prevention of venous thrombosis of the calf muscles immediately after surgery Program P9 corresponds to EMS mode.
Device Story
Connected TENS/EMS device; generates electrical impulses via skin electrodes; controlled by mobile app for program selection, channel management, intensity, and duration. Used at home by patients or by medical professionals. Device fixes to body via fastening accessory; flexible design adapts to body shape. Output affects nerve/muscle tissue to manage pain, relax spasms, or re-educate muscles. Benefits include discreet pain management and muscle therapy during daily activities. EIG monitors impedance to ensure proper electrode contact; stops stimulation if impedance is out of range to prevent discharge.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including electrical safety (IEC 60601-1, 60601-2-10), EMC, biocompatibility (ISO 10993), software validation, and usability testing.
Technological Characteristics
Battery-powered (Li-ion) EIG; ABS housing; stainless steel connectors. Compensated asymmetrical biphasic waveform. Regulated current output (max 60mA/60V). Connectivity via mobile app. Complies with IEC 60601-1, IEC 60601-2-10, ISO 10993, and IEC 62304. Non-sterile.
Indications for Use
Indicated for adults >22 years with chronic intractable pain, post-surgical/post-trauma acute pain, arthritis, and muscle-related conditions (spasms, atrophy, blood flow, range of motion, venous thrombosis prevention). Available for OTC and prescription use.
Regulatory Classification
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Predicate Devices
Related Devices
- K180943 — BioWaveGO · Biowave Corporation · Aug 17, 2018
- K173462 — Wireless Pain Relieve Device Model: LT5018C · Shenzhen Dongdixin Technology Co., Ltd. · Dec 8, 2017
- K160052 — CUR Model 1 · Thimble Bioelectronics, Inc. · May 20, 2016
- K200177 — Low-frequency Multi-function physiotherapy instrument · Shenzhen Kentro Medical Electronics Co., Ltd. · Mar 25, 2021
- K202159 — actiTENS · Sublimed · Dec 22, 2020
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
January 16, 2026
Sublimed
% Rob Packard
Regulatory Consultant
Medical Device Academy
345 Lincoln Hill Road
Shrewsbury, Vermont 05738
Re: K252767
Trade/Device Name: actiTENS mini
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: GZJ, NYN, IPF, NGX, NUH
Dated: December 18, 2025
Received: December 18, 2025
Dear Rob Packard:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K252767 - Rob Packard
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K252767 - Rob Packard
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
AMBER T. BALLARD -S
Amber Ballard, PhD
Assistant Director
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252767 | |
| Device Name actiTENS mini | |
| Indications for Use (Describe) Over-the-counter use : actiTENS Mini is intended to be used as: | |
| Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. | |
| Prescription use: actiTENS Mini is intended to be used as: | |
| Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Adjunctive treatment for post-surgical and post-trauma acute pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. | |
| Electrical Muscle Stimulation (EMS), used for the following indications: -Temporary relaxation of muscle spasms -Prevent or retard disuse atrophy -Increase of local blood flow in the treatment area -Re-educate muscles -Maintain or increase the range of motion -Prevention of venous thrombosis of the calf muscles immediately after surgery Program P9 corresponds to EMS mode. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
**DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.**
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 2 of 2
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SUBLIMED
actiTENS mini 510(k) Submission
# 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
# I. SUBMITTER INFORMATION
## APPLICANT
Company Name: Sublimed
Address: 137 rue mayoussard
City, State, Zip: Moirans 38430 France
Tel: +33668050114
Contact Name: Mr. Adrien Hallet
Contact Email: adrien.hallet@subli-med.com
## CORRESPONDENT
Company Name: Medical Device Academy, Inc.
Address: 345 Lincoln Hill Road
City, State, Zip: Shrewsbury, VT 05738 USA
Tel: +1.802.258.1881
Contact Name: Rob Packard
Contact Email: rob@fdaestar.com
Date Prepared: January 14, 2026
# II. NAME OF THE DEVICE
Device Trade Name: actiTENS mini
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
Regulation: 21 CFR 882.5890
Regulatory Class: Class 2
Device Panel: Neurology
Classification Product Code: GZJ
Associated Product Codes: NYN, IPF, NGX, NUH
# III. IDENTIFICATION OF THE PREDICATE
## Primary Predicate
Predicate Manufacturer: Sublimed
Predicate Trade Name: actiTENS
Predicate 510(k): K202159
## Secondary Predicate
Predicate Manufacturer: JKH USA, LLC
Predicate Trade Name: JKH Stimulator Plus
Predicate 510(k): K182203
No reference devices were used in this submission.
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
## IV. DESCRIPTION OF THE DEVICE
The actiTENS mini is a connected medical device for transcutaneous electrical nerve stimulation (TENS) intended to treat pain in adults. It also contains an electrical muscle strengthening (EMS) program. It is intended for people over 22 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on the body using a fastening accessory. It adapts to the shape of the body with its flexible design. The actiTENS mini can be used discreetly during daily activities.
The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing: a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration.
It is intended to be used by the patient at home and for therapeutic application by medical professionals.
## V. STATEMENT OF INTENDED USE
### Over-the-counter use:
actiTENS mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
- Symptomatic relief and management of chronic, intractable pain
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
- Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.
### Prescription use:
actiTENS mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
- Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.
Electrical Muscle Stimulation (EMS), used for the following indications:
- Temporary relaxation of muscle spasms
- Prevent or retard disuse atrophy
- Increase of local blood flow in the treatment area
- Re-educate muscles
- Maintain or increase the range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
# INDICATIONS FOR USE COMPARISON
The subject device and primary predicate device (K202159) have the same indications for use with the exception that the predicate device does not include over-the-counter-use.
The subject device and the predicate device (K182203) have equivalent indications for use, including over-the-counter use.
# VI. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
## TECHNOLOGICAL COMPARISON
The subject device, primary predicate device, and secondary predicate device have equivalent technological characteristics. All three devices claim one function: electrical stimulation. Concerning the maximum output voltage and the maximum output current, the subject device and the primary predicate device have been developed as a current generator with a maximum setpoint current of $60\mathrm{mA}$ and has been limited by hardware to deliver output voltage of $60\mathrm{V}$. Thus it delivers a current of $60\mathrm{mA}$ at $60\mathrm{V}$ for $1\mathrm{K}\Omega$. Above this charge the maximum output power will decrease. In both cases the maximum output current and maximum output voltage of the subject device are in the same range to this of the predicate. The subject device presents a maximum phase charge in the same range to this of the predicate device. The maximum current density and maximum average power density are directly linked to the electrodes surfaces used with the device. They are calculated for the subject device using the smallest electrodes provided/recommended for use, the values stay in the same order of magnitude as this of the predicate device. For the maximum current density it stays under $2\mathrm{mA/cm^2}$, and the maximum power density stays well under $0.25\mathrm{W/cm^2}$. These technological differences between the subject and predicate device do not impact safety and effectiveness.
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
# VII. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
Table 1: Comparison of actiTENS mini (K252767) with actiTENS (K202159).
| | actiTENS mini (K252767) | actiTENS (K202159) | Justification for differences |
| --- | --- | --- | --- |
| Indications for Use | Over-the-counter: actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: - Symptomatic relief and management of chronic, intractable pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities - Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. | actiTENS is intended to be used as: • Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities - Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode. | NA: Same indications for use. OTC claims justified with secondary predicate device. |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| | - Prescription use: actiTENS Mini is intended to be used as:
- Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
- Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. | • Electrical Muscle Stimulation (EMS), used for the following indications:
- Temporary relaxation of muscle spasms
- Prevent or retard disuse atrophy
- Increase of local blood flow in the treatment area
- Re-educate muscles
Maintain or increase the range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode. | |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| | Electrical Muscle Stimulation (EMS), used for the following indications: - Temporary relaxation of muscle spasms - Prevent or retard disuse atrophy - Increase of local blood flow in the treatment area - Re-educate muscles - Maintain or increase the range of motion - Prevention of venous thrombosis of the calf muscles immediately after surgery Program P9 corresponds to EMS mode. | | |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| Materials | actiTENS mini Electric Impulse Generator (EIG): | Not publicly disclosed | Biocompatibility assessment in accordance to ISO 10993-1 |
| --- | --- | --- | --- |
| | - housing: Acrylonitrile
Butadiene Styrene (ABS) M203FC/ Ink: TPR P541C/ Diluent TPV | | |
| | - blue button: Thermolast M TM7ADT Naturel/ 3% PP5M176173-ZN mevopur dark blue | | |
| | - blue plastic wire-pass: Thermolast M TM6LFT Naturel + 3% PP5M176173-ZN mevopur dark blue | | |
| | - snap-in cable connector: Stainless Steel 316L | | |
| | - Velcro: Polypropylene ULTRAMATE® HTH 830 + PS30 | | |
| | - on-plastic labeling: THERMLfilm® ADVANTAGE™ Extreme Range with EFI Jetrion 4000/4830 Series Ink Set | | |
| | **Self-adhesive strips:** | | |
| | - Velcro: Velour 3165 Std. + adhesive PS30 | | |
| | - Main part: Medical grade silicon | | |
| | **Textile accessories:** | | |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| | - Main fabric: Polyamide 58%, Polyester 30%, Elastane 12% - Buckle and Velcro: Polyamide
**Electrodes:** (have their own 510(k): K160138 ): Biocompatible hydrogel conductor, conducting part: carbon + PE; insulating base material: non-woven PET fibre, snap connector: stainless steel
**Low back electrodes/multisite electrode:** (have their own 510(k): K160138 ): )Biocompatible hydrogel conductor, conducting part: vinyl carbon; insulating base material: non-woven PET 25 microns, Velcro: Velour 3165, snap connector: stainless steel 316.
**Sensitive skin electrodes:** (have their own 510(k): K130987): Hydrogel conductor (Polyethylene Glycol, water, polyvinyl pyrrolidone, magnesium acetate) and stainless steel knit cloth. | | |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| | UltraStim® snap
Electrodes: have their own 510(k): K130987. for material composition please refer to their own 510((k)).
Cables: Overmolding parts: TPU, Cable conductive film: TPU, Metallic part of the snap: Nickeled brass
AC charger: plastic housing: Polycarbonate | | |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| Design | The actiTENS mini kit is composed of a portable generator, cables, electrodes, charger, and a transport bag:
Electrodes: actiTENS mini electrodes (5 references detailed below)
Cables: actiTENS mini cables used to connect actiTENS mini EIG SBM7AA100 and electrodes
Power supply/ Charging system: 1 Li-Ion battery
**The standard actiTENS mini kit includes the following elements:**
- 1 actiTENS mini
- 1 armband actiTENS 70cm
- 1 pack of 2 medium cables of 14 cm
- 1 pack of 2 medium cables of 40 cm
- 1 pack of 2 medium cables of 70 cm
- 1 pack of 4 electrodes 50mm x 50mm
- To charge the device: | Not publicly disclosed | The main difference in the composition of the kit is the charging system:
To charge the actiTENS device, the EIG must be in the charging case, and the charging case plugged into the AC Charger.
actiTENS mini kit does not include the charging case. To charge the device, the EIG is plugged directly into the mains charger via a USB-C port with 2 MOPP. A risk analysis was carried out and risk controls were implemented to ensure that this change does not affect the safety and effectiveness of the device.
Finally, actiTENS mini offers optional accessories purchased separately, giving users variety (cable length, electrodes sizes, etc) for treatment. |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| | ○ 1 AC charger
- 1 IFU
**Optional accessories:**
- Pack of 4 round electrodes diameter 32mm
- Pack of 4 round electrodes diameter 50mm
- Pack of 4 rectangular electrodes 50 x 90mm
- 1 pack of 4 electrodes 50mm x 50mm
- Low back electrode
- Multisite electrode
- Sensitive skin Electrodes
- UltraStim® snap Electrodes
- Pack of 2 cables 100 cm long
- Textile fastening accessories
1 pack of 2 self-adhesive supports to fix 1 actiTENS mini on the body | | |
| --- | --- | --- | --- |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| Product classification | GZJ, NGX, NYN, IPF, NUH | GZJ, NGX, NYN, IPF | The subject device includes an additional product classification code of NUH. The risks of OTC indications are addressed by the use of a secondary predicate. |
| --- | --- | --- | --- |
| Prescription or OTC | OTC and Prescription | Prescription | actiTENS mini has a secondary predicate device that is OTC for assessing substantial equivalence |
| Other Features | To be used with actiTENS Mobile app | To be used with actiTENS Mobile app | Same mobile app. |
| Power source(s) | Battery powered (1 rechargeable Li-ion battery) | Battery powered (2 rechargeable Li-Ion batteries) | actiTENS, with two batteries, and actiTENS mini, with one battery, both provide the same maximum power output of 0.222W. Therefore, this difference does not impact the safety and effectiveness of the device. |
| - Method of Line current Isolation | Output is electrically disabled when connect to charger via microprocessor charging circuit | Output is electrically disabled when connect to charger via microprocessor charging circuit | Same method of line current isolation |
| - Patient leakage current: Normal condition (μA) | NA battery powered | Not publicly disclosed | Values of the predicate are not publicly available. |
| - Patient leakage current: Single Fault condition (μA) | NA battery powered | Not publicly disclosed | Values of the predicate are not publicly available. |
| Number of output modes | 1 (Maximum 60V and 60mA) | Not publicly disclosed | Values of the predicate are not publicly available. |
| Waveform | Compensated asymmetrical biphasic waves | asymmetrical biphasic waves | Same waveform. |
| Shape | Rectangular | Not publicly disclosed | Values of the predicate are not publicly available. |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Voltage (Volts) (+/- 20 %) at 500 Ω | P1:29,3 | P1: 30,2 | Maximum output voltage of the subject device is in the range or below this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2:29,3 | P2: 30,2 | |
| | P3:29,3 | P3: 30 | |
| | P4:29,3 | P4: 30,2 | |
| | P5:29,3 | P5: 30,2 | |
| | P6:29,3 | P6: 30 | |
| | P7:29,3 | P7: 30,2 | |
| | P8: | P8:30, | |
| | 29,3 | 2 NA | |
| | P9 min (30 Hz - 150 μs): 29,3 | P9: | |
| | P9 - EMS 1: 29,3 | 29,5 | |
| | P9 max (80 Hz - 400 μs): 29,3 | NA | |
| | P10: 29,3 | P10: 29,1 | |
| | P11: 29,3 | P11: 29,3 | |
| | P12: 29,3 | P12: 30,2 | |
| | P13: 29,3 | P13: | |
| | P15 min (1 Hz - 50 μs): 29,3 | 30,2 NA | |
| | P15 max (120 Hz - 400 μs): 29,3 | NA | |
510(k) Summary
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SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Voltage (Volts) (+/- 20 %) at 2 kΩ | P1: 58 | P1: 57,9 | Maximum output voltage of the subject device is very near to this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 58 | P2: 57,9 | |
| | P3: 58 | P3: 57,9 | |
| | P4: 58 | P4: 57,9 | |
| | P5: 58 | P5: 57,9 | |
| | P6: 58 | P6: 57,9 | |
| | P7: 58 | P7: 57,9 | |
| | P8: 58 | P8:57,9 | |
| | P9 min (30 Hz - 150 μs): 58 | NA | |
| | P9 - EMS 1: 58 | P9:57,9 | |
| | P9 max (80 Hz - 400 μs): 59 | NA | |
| | P10: 58 | P10: 57,9 | |
| | P11: 58 | P11: 57,9 | |
| | P12: 58 | P12: 57,9 | |
| | P13: 58 | P13:57,9 | |
| | P15 min (1 Hz - 50 μs): 58 | NA | |
| | P15 max (120 Hz - 400 μs): 58 | NA | |
510(k) Summary
Page 14 of 56
{19}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Voltage (Volts) (+/- 20 %) at 10 kΩ | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient from feeling an electric discharge as the attached surface diminishes. The 10 kOhm is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient feeling an electric discharge as the attached surface diminishes. The 10kΩ is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed. | NA: no differences |
| --- | --- | --- | --- |
510(k) Summary
Page 15 of 56
{20}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Current (mA) (+/-20%) at 500 Ω calculated: I(A) = U(V) / R(Ω) with U = value #I(V) and R = 500 Ω This result is multiplied by 10^3 to obtain I in mA | P1:58,6 | P1:60,4 | Maximum output current of the subject device is in the range or below this of the predicate device. They are under the maximum average current of 10 mA into a load of 500 ohms defined in the ANSI AAMI NS4 § 3.2.2.2. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 58,6 | P2:60,4 | |
| | P3: 58,6 | P3:60 | |
| | P4: 58,6 | P4:60,4 | |
| | P5: 58,6 | P5:60,4 | |
| | P6: 58,6 | P6:60 | |
| | P7: 58,6 | P7:60,4 | |
| | P8: 58,6 | P8:60,4 | |
| | P9 min (30 Hz - 150 μs): 58,6 | NA P9:59 | |
| | P9 - EMS 1: 58,6 | NA | |
| | P9 max (80 Hz - 400 μs): 58,6 | P10:58,2 | |
| | P10: 58,6 | P11:58,6 | |
| | P11: 58,6 | P12:60,4 | |
| | P12: 58,6 | P13:60,4 | |
| | P13: 58,6 | NA | |
| | P15 min (1 Hz - 50 μs): 58,6 | NA | |
| | P15 max (120 Hz - 400 μs): 58,6 | | |
510(k) Summary
Page 16 of 56
{21}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Current (mA) (+/-20%) at 2 kΩ | P1: 29 | P1: 28,95 | Maximum output current of the subject device is very near to this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 29 | P2: 28,95 | |
| | P3: 29 | P3: 28,95 | |
| | P4: 29 | P4: 28,95 | |
| | P5: 29 | P5: 28,95 | |
| | P6: 29 | P6: 28,95 | |
| | P7: 29 | P7: 28,95 | |
| | P8: 29 | P8:28,95 | |
| | P9 min (30 Hz - 150 μs): 29 | NA | |
| | P9 - EMS 1: 29 | P9:28,95 | |
| | P9 max (80 Hz - 400 μs): 29,5 | NA | |
| | P10: 29 | P10: 28,95 | |
| | P11: 29 | P11: 28,95 | |
| | P12: 29 | P12: 28,95 | |
| | P13: 29 | P13:28,95 | |
| | P15 min (1 Hz - 50 μs): 29 | NA | |
| P15 max (120 Hz - 400 μs): 29 | NA | | |
510(k) Summary
Page 17 of 56
{22}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Output Current (mA) (+/-20%) at 10 kΩ | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient from feeling an electric discharge as the attached surface diminishes. The 10 kOhm is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient feeling an electric discharge as the attached surface diminishes. The 10kΩ is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed | NA: no differences |
| --- | --- | --- | --- |
510(k) Summary
Page 18 of 56
{23}
SUBLIMED
actiTENS mini 510(k) Submission
| Pulse Width (μs) | P1: 198 | P1: 197,5 | Pulse width of the subject device is very near to this of the predicate device for the corresponding programs. Extra programs have lower (47 μs vs 100 μs) and higher (up to 398 μs vs 247,5 μs) pulse width, staying in the same order of magnitude. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 148 | P2: 147 | |
| | P3: 248 | P3: 247,5 | |
| | P4: 198 | P4: 197,5 | |
| | P5: 148 | P5: 147,5 | |
| | P6: 198 or 148 | P6: 200 or 147 | |
| | P7: 148 | P7: 147,5 | |
| | P8: modulated 98 -198 | P8: modulated 100- | |
| | P9 min (30 Hz - 150 μs): 147,5 | 200 NA | |
| | P9 - EMS 1: 248 | P9:247,5 | |
| | P9 max (80 Hz - 400 μs): 397 | NA | |
| | P10: 148 | P10: 147,5 | |
| | P11: 148 | P11: 147,5 | |
| | P12: 58 | P12: 57,5 | |
| | P13: 178 | P13:177,5 | |
| | P15 min (1 Hz - 50 μs): 47 | NA | |
| | P15 max (120 Hz - 400 μs): 398 | NA | |
510(k) Summary
Page 19 of 56
{24}
SUBLIMED
actiTENS mini 510(k) Submission
| Frequency (Hz) | P1: 100,06 | P1: 100 | Frequency of the subject device is very near to this of the predicate device for the corresponding programs. Extra programs have lower (1 Hz vs 2 Hz) and higher (up to 120 Hz vs 100 Hz) frequency, staying in the same order of magnitude. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 80,022 | P2: 80 | |
| | P3: 2,0006 | P3: 2 | |
| | P4: 100,06 | P4: 100 | |
| | P5: 100,03 | P5: 100 | |
| | P6: 2 or 100 | P6: 2 or 100 | |
| | P7: 100 | P7: 100 | |
| | P8: modulated 2 - 80 | P8: modulated 2- | |
| | P9 min (30 Hz - 150 μs): 30 | 80 NA | |
| | P9 - EMS 1: 50,02 | P9:50 | |
| | P9 max (80 Hz - 400 μs): 80 | NA | |
| | P10: 80,02 | P10: 80 | |
| | P11: 80,02 | P11: 80 | |
| | P12: 80,06 | P12: 80 | |
| | P13: 10,006 | P13: 10 | |
| | P15 min (1 Hz - 50 μs): | NA | |
| | 1,0003 P15 max (120 Hz - 400 μs): 120,08 | NA | |
| For interferential modes only: - Beat Frequency (Hz) | NA : not interferential mode | Not publicly disclosed | Values of the predicate are not publicly available. |
| For multiphasic waveforms only: - Symmetrical phases? Yes / No | Biphasic | Biphasic | Same. |
| | - No, asymmetrical | - No, asymmetrical | |
| | Phase 1 : corresponds to the pulse width Phase 2 (discharge duration) : 120 μs +/- 10 μs | not publicly disclosed | Values of the predicate are not publicly available. |
| - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | | | |
510(k) Summary
{25}
SUBLIMED
actiTENS mini 510(k) Submission
| Net Charge (μC per pulse) at 500Ω | 0 | Not publicly disclosed | Values of the predicate are not publicly available. Zero net charge is obtained through compensated asymmetrical biphasic waves. |
| --- | --- | --- | --- |
| Maximum Phase Charge (μC) at 500 Ω calculated: Q(C) = I(A) x d(s) with I and d values measured above. This result is multiplied by 10^6 to obtain Q in μC | P1: 11,6 | P1: 11,9 | Maximum phase charge of the subject device is very near to this of the predicate device for the corresponding programs. Extra programs have lower (2,8 μC vs 3,5 μC) and higher (up to 23,3 μC vs 14,9 μC) maximum phase charge, staying in the same order of magnitude. They are under the maximum charge per pulse of 31,2 μC defined in the ANSI AAMI NS4 § 3.2.2.2. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| | P2: 8,7 | P2: 8,9 | |
| | P3: 14,5 | P3: 14,9 | |
| | P4: 11,6 | P4: 11,9 | |
| | P5: 8,7 | P5: 8,9 | |
| | P6: 8,7 to 11,6 | P6: 12,1 | |
| | P7: 8,7 | P7: 8,9 | |
| | P8: 5,7 to 11,6 | P8: 6,0 to | |
| | P9 min (30 Hz - 150 μs): 8,6 | 12,1 NA | |
| | P9 - EMS 1: 14,5 | P9:14,6 | |
| | P9 max (80 Hz - 400 μs): 23,3 | NA | |
| | P10: 8,7 | P10: 8,6 | |
| | P11: 8,7 | P11: 8,6 | |
| | P12: 3,4 | P12: 3,5 | |
| | P13: 10,4 | P13:10,7 | |
| | P15 min (1 Hz - 50 μs): | NA | |
| | 2,8 P15 max (120 Hz - 400 μs): 23,3 | NA | |
510(k) Summary
{26}
SUBLIMED
actiTENS mini 510(k) Submission
| conductive surface area of the smallest electrodes provided/recommended for use with the unit (cm²)
calculated:
- for actiTENS mini: round electrodes of diameter 32 mm S (cm²) = π x (3,2 / 2)²
- for actiTENS: square electrodes of side length 4,5 cm S (cm²) = 4,5 x 4,5 | 8.0 | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
510(k) Summary
Page 22 of 56
{27}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Current Density (mA/cm2) at 500 Ω calculated along Guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p13-14. Maximum current density (mA/cm2) = I (mA) x f (Hz) x d (s) / S (cm2) With I, f, d and S values measured above | P1: 0,144 | P1: 0,059 | Maximum current density of the subject device stays in the same order of magnitude as this of the predicate device (from 0,0003 mA/cm2 vs 0,001 mA/cm2 up to 0,348 mA/cm2 vs 0,059 mA/cm2). These values stay under 2 mA/cm2. These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: 0,086 | P2: 0,035 | |
| | P3: 0,004 | P3: 0,001 | |
| | P4: 0,144 | P4: 0,059 | |
| | P5: 0,108 | P5: 0,044 | |
| | P6: 0,003 or 0,108 | P6: 0,001 or 0,044 | |
| | P7: 0,108 | P7: 0,044 | |
| | P8: 0,003 or 0,057 | P8: 0,001 to | |
| | P9 min (30 Hz - 150 μs): 0,032 | 0,024 NA | |
| | P9 - EMS 1: 0,090 | P9:0,036 | |
| | P9 max (80 Hz - 400 μs): 0,231 | NA | |
| | P10: 0,086 | P10: 0,034 | |
| | P11: 0,086 | P11: 0,034 | |
| | P12: 0,034 | P12: 0,014 | |
| | P13: 0,013 | P13:0,005 | |
| | P15 min (1 Hz - 50 μs): 0,000 | NA | |
| P15 max (120 Hz - 400 μs): 0,348 | NA | | |
510(k) Summary
{28}
SUBLIMED
actiTENS mini 510(k) Submission
| Maximum Power Density (mW/cm2) at 500 Ω calculated along Guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p13-14. Maximum power density (mW/cm2) = U(V) x Maximum current density (mA/cm2) with U and Maximum current density measured above | P1: 4,23 | P1: 1,78 | Maximum power density of the subject device stays in the same order of magnitude as this of the predicate device (from 0,01 mW/cm2 vs 0,04 mW/cm2 up to 10,20 mW/cm2 vs 1,78 mW/cm2). These values stay well under 0,25 W/cm2 as required by the guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p 14, to reduce the risk of thermal burns. These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: 2,53 | P2: 1,06 | |
| | P3: 0,11 | P3: 0,04 | |
| | P4: 4,23 | P4: 1,78 | |
| | P5: 3,16 | P5: 1,33 | |
| | P6: 0,08 or 3,160 | P6: 0,04 or 1,31 | |
| | P7: 3,16 | P7: 1,33 | |
| | P8: 0,08 to 1,67 | P8: 0,04 to | |
| | P9 min (30 Hz - 150 μs): 0,94 | 0,72 NA | |
| | P9 - EMS 1: 2,65 | P9:1,06 | |
| | P9 max (80 Hz - 400 μs): 6,78 | NA | |
| | P10: 2,53 | P10: 0,99 | |
| | P11: 2,53 | P11: 1,00 | |
| | P12: 0,99 | P12: 0,41 | |
| | P13: 0,38 | P13:0,16 | |
| | P15 min (1 Hz - 50 μs): | NA | |
| 0,01 P15 max (120 Hz - 400 μs): 10,20 | NA | | |
| Burst Mode (i.e., pulse trains) a. Pulses per burst b. Bursts per second c. Burst duration (seconds) d. Duty Cycle [Line (b) x Line (c)] | All programs except P7: NA (continuous) Burst mode for TENS functionality: P7 a: 25 b: 2 c: 0.25 d: 0.5 | Not publicly disclosed | Values of the predicate are not publicly available. |
510(k) Summary
{29}
SUBLIMED
actiTENS mini 510(k) Submission
| ON Time (seconds) | P1: NA (continuous)
P2: NA (continuous)
P3: NA (continuous)
P4: NA (continuous)
P5: NA (continuous)
P6: NA (continuous)
P7: NA (burst)
P8: NA (continuous)
P9 min (30 Hz - 150 μs): 1
P9 - EMS 1: 5
P9 max (80 Hz - 400 μs): 60 P10: NA
(continuous) P11: NA
(continuous) P12: NA
(continuous) P13: NA
(continuous)
P15 min (1 Hz - 50 μs): NA
(continuous)
P15 max (120 Hz - 400 μs): NA
(continuous) | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
510(k) Summary
Page 25 of 56
{30}
SUBLIMED
actiTENS mini 510(k) Submission
| OFF Time (seconds) | P1: NA (continuous) | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
| | P2: NA (continuous) | | |
| | P3: NA (continuous) | | |
| | P4: NA (continuous) | | |
| | P5: NA (continuous) | | |
| | P6: NA (continuous) | | |
| | P7: NA (burst) | | |
| | P8: NA (continuous) | | |
| | P9 min (30 Hz - 150 μs): 60 | | |
| | P9 - EMS 1: 12 | | |
| | P9 max (80 Hz - 400 μs): | | |
| | 1 P10: NA (continuous) | | |
| | P11: NA (continuous) | | |
| | P12: NA (continuous) | | |
| | P13: NA (continuous) | | |
| | P15 min (1 Hz - 50 μs): NA (continuous) | | |
| | P15 max (120 Hz - 400 μs): NA (continuous) | | |
| Additional features | NA | Not publicly disclosed | no additional features |
| Number of output channels
- Synchronous or Alternating?
- Method of Channel Isolation: | 2
- Alternating
- Mechanical | Not publicly disclosed | Values of the predicate are not publicly available. |
| Regulated Current or Regulated Voltage? | Regulated current | Not publicly disclosed | Values of the predicate are not publicly available. |
| Software/Firmware/Microprocessor Control? | Yes, software control | Not publicly disclosed | Values of the predicate are not publicly available. |
| Automatic Overload Trip? | No, overload not possible by design | Not publicly disclosed | Values of the predicate are not publicly available. |
510(k) Summary
Page 26 of 56
{31}
SUBLIMED
actiTENS mini 510(k) Submission
| Automatic No-Load Trip? | Yes, verification step during program launch and stimulation stops in case of detection of no-load. | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
| Automatic Shut Off? | Yes, the generator turns off after 10 minutes of no activity. | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
| Patient Override Control? | Yes, through the mobile app | Not publicly disclosed | Values of the predicate are not publicly available. |
| Timer Range (minutes) | Session duration:10 -720, adjustable via the mobile app | Not publicly disclosed | Values of the predicate are not publicly available. |
| Compliance with Voluntary Standards? | Yes (specified at the end of this document*) | Yes | NA: actiTENS mini complies with the standards to which actiTENS complies |
| Compliance with 21 CFR 898? | Yes | Yes | NA: No difference |
| Weight | ~ 60 g | Not publicly disclosed | Values of the predicate are not publicly available. This doesn’t have an impact on safety and effectiveness of the device. |
| Dimensions (mm) [W x H x D] | 92 mm x 15 mm x 56 mm | Not publicly disclosed | Values of the predicate are not publicly available. This doesn’t have an impact on safety and effectiveness of the device. |
| Indicator Display: - ON/OFF status? - Low battery? - Current level? | Yes:LED indicator / mobile app Yes:Indicated on the mobile app Yes:Indicated on the mobile app | Yes:LED indicator / mobile app Yes:Indicated on the mobile app Yes:Indicated on the mobile app | Values of the predicate are not publicly available. |
510(k) Summary
{32}
SUBLIMED
actiTENS mini 510(k) Submission
| Performance Testing | The following benchtop performance testing was performed:
**Transportation Testing:** - Transportation test report
**Self-adhesive strips wearability:** - Wearability test report of the self-adhesive strips
**Interoperability:** - Validation report of the system
**Usability Testing:** - Validation plan - Usability Engineering File - Usability Engineering File – final validation report | The following benchtop performance testing was performed:
**Transportation Testing:** - Transportation test report
**Self-adhesive strips wearability:** - Wearability test report of the self-adhesive strips
**Interoperability:** - Validation report of the system
**Usability Testing:** - Validation plan - Usability Engineering File - Usability Engineering File – final validation report | NA: Same testing. |
| --- | --- | --- | --- |
510(k) Summary
Page 28 of 56
{33}
SUBLIMED
actiTENS mini 510(k) Submission
Table 2: Comparison of actiTENS mini (K252767) with JKH Stimulator Plus (K182203).
| | actiTENS mini (K252767) | JKH Stimulator Plus (K182203) | Justification for differences |
| --- | --- | --- | --- |
510(k) Summary
{34}
SUBLIMED
actiTENS mini 510(k) Submission
| Indications for Use | Over-the-counter use : actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: - Symptomatic relief and management of chronic, intractable pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities - Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. Prescription use: actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: | Over-the-Counter Use: TENS (Modes 1, 2, 4, 6, 8): PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household work activities. PL-0219K12 and PL-029K13 are also intended for symptomatic relief an management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes. PMS (also called EMS, Modes 1, 3, 7): PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains. | Same indications for use as Model PL-029K12 (i.e., no heating function). |
| --- | --- | --- | --- |
510(k) Summary
{35}
SUBLIMED
actiTENS mini 510(k) Submission
| | - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities - Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.
**Electrical Muscle Stimulation (EMS)**, used for the following indications: - Temporary relaxation of muscle spasms - Prevent or retard disuse atrophy - Increase of local blood flow in the treatment area - Re-educate muscles - Maintain or increase the range of motion - Prevention of venous thrombosis of the calf muscles immediately | Prescription Use: PL-029K12 and PL-029K13 are intended for the following use: - Symptomatic relief and management of chronic, interactable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles |
| --- | --- | --- |
510(k) Summary
Page 31 of 56
{36}
SUBLIMED
actiTENS mini 510(k) Submission
| | after surgery
Program
corresponds
EMS mode. | P9
to | | |
| --- | --- | --- | --- | --- |
510(k) Summary
Page 32 of 56
{37}
SUBLIMED
actiTENS mini 510(k) Submission
| Materials | actiTENS mini Electric Impulse Generator (EIG): | Not publicly disclosed | Biocompatibility assessment in accordance to ISO 10993-1 |
| --- | --- | --- | --- |
| | - housing: Acrylonitrile
Butadiene Styrene (ABS) M203FC/ Ink: TPR P541C/ Diluent TPV | | |
| | - blue button: Thermolast M TM7ADT Naturel/ 3% PP5M176173-ZN mevopur dark blue | | |
| | - blue plastic wire-pass: Thermolast M TM6LFT Naturel + 3% PP5M176173-ZN mevopur dark blue | | |
| | - snap-in cable connector: Stainless Steel 316L | | |
| | - Velcro: Polypropylene ULTRAMATE® HTH 830 + PS30 | | |
| | - on-plastic labeling: THERMLfilm® ADVANTAGE™ Extreme Range with EFI Jetrion 4000/4830 Series Ink Set | | |
| | **Self-adhesive strips:** | | |
| | - Velcro: Velour 3165 Std. + adhesive PS30 | | |
| | - Main part: Medical grade silicon | | |
| | **Textile accessories:** | | |
510(k) Summary
Page 33 of 56
{38}
SUBLIMED
actiTENS mini 510(k) Submission
| | - Main fabric: Polyamide 58%, Polyester 30%, Elastane 12% - Buckle and Velcro: Polyamide
**Electrodes:** (have their own 510(k): K160138 ): Biocompatible hydrogel conductor, conducting part: carbon + PE; insulating base material: non-woven PET fiber, snap connector: stainless steel
**Low back electrodes/multisite electrode:** (have their own 510(k): K160138 ): )Biocompatible hydrogel conductor, conducting part: vinyl carbon; insulating base material: non-woven PET 25 microns, Velcro: Velour 3165, snap connector: stainless steel 316.
**Sensitive skin electrodes:** (have their own 510(k): K130987): Hydrogel conductor (Polyethylene Glycol, water, polyvinyl pyrrolidone, magnesium acetate) and stainless steel knit cloth.
**UltraStim® snap Electrodes:** have their own | | |
| --- | --- | --- | --- |
510(k) Summary
Page 34 of 56
{39}
SUBLIMED
actiTENS mini 510(k) Submission
| | 510(k): K130987. for material composition please refer to their own 510((k).
**Cables:** Overmolding parts: TPU, Cable conductive film: TPU, Metallic part of the snap: Nickeled brass
**AC charger:** plastic housing: Polycarbonate | | |
| --- | --- | --- | --- |
510(k) Summary
Page 35 of 56
{40}
SUBLIMED
actiTENS mini 510(k) Submission
| Design | The actiTENS mini kit is composed of a portable generator, cables, electrodes, charger, and a transport bag:
Electrodes: actiTENS mini electrodes (5 references detailed below)
Cables: actiTENS mini cables used to connect actiTENS mini EIG SBM7AA100 and electrodes
Power supply/ Charging system: 1 Li-Ion battery
**The standard actiTENS mini kit includes the following elements:**
- 1 actiTENS mini
- 1 armband actiTENS 70cm
- 1 pack of 2 medium cables of 14 cm
- 1 pack of 2 medium cables of 40 cm
- 1 pack of 2 medium cables of 70 cm
- 1 pack of 4 electrodes 50mm x 50mm
- To charge the device: | Electrical stimulation and heat | The subject device does not include the IRT product classification, and this eliminates the risks associated with that function. |
| --- | --- | --- | --- |
510(k) Summary
Page 36 of 56
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SUBLIMED
actiTENS mini 510(k) Submission
| | ○ 1 AC charger
- 1 IFU
**Optional accessories:**
- Pack of 4 round electrodes diameter 32mm
- Pack of 4 round electrodes diameter 50mm
- Pack of 4 rectangular electrodes 50 x 90mm
- 1 pack of 4 electrodes 50mm x 50mm
- Low back electrode
- Multisite electrode
- Sensitive skin Electrodes
- UltraStim® snap Electrodes
- Pack of 2 cables 100 cm long
- Textile fastening accessories
1 pack of 2 self-adhesive supports to fix 1 actiTENS mini on the body | | |
| --- | --- | --- | --- |
510(k) Summary
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| Product Classifications | GZJ, NGX, NYN, IPF, NUH | NUH, NGX, NYN, IRT, GZJ, IPF | The subject device does not include the IRT product classification, and this eliminates the risks associated with the heating function/indication. |
| --- | --- | --- | --- |
| Prescription or OTC | OTC and Prescription | OTC and Prescription | NA: Same |
| Energy Source | 1 rechargeable Li-Ion battery | Rechargeable or non-rechargeable battery | actiTENS mini, with one rechargeable Li-Ion battery, provides a maximum power output of 0.222W; while the secondary predicate permits use of a rechargeable or non-rechargeable battery. The differences in the energy source from the secondary predicate do not impact the safety and effectiveness of the subject device. |
| Power source(s) | Battery powered (1 rechargeable Li-ion battery) | Rechargeable or non-rechargeable battery | NA: both are battery powered |
| - Method of Line current Isolation | Output is electrically disabled when connect to charger by means of microprocessor charging circuit | Battery Supply | Same method of line current isolation |
| - Patient leakage current: Normal condition (μA) | NA: battery powered | NA | Same |
| - Patient leakage current: Single Fault condition (μA) | NA: battery powered | NA | Same |
| Number of output modes | 1 (Maximum 60V and 60mA) | 8 (Maximum 134V and 152mA) | Maximum output voltage of the subject device is in the range or below this of the secondary predicate device. These technological differences between the subject device and the predicate do not impact safety and effectiveness. |
| Waveform | Compensated asymmetrical biphasic | Not publicly disclosed | Values of the predicate are not publicly available, |
| Shape | Rectangular | Not publicly disclosed | Values of the predicate are not publicly available. |
510(k) Summary
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| Maximum Output Voltage (Volts) (+/- 20 %) at 500 Ω | P1:29, | Mode 1: This mode cycles the following modes | Maximum output voltage of the subject device is in the range or below this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | 3 | Mode 2: 36,4 | |
| | P2:29, | Mode 2: 47.6 | |
| | 3 | Mode 3: 57.6 | |
| | P3:29,3 | Mode 4: 29.6 | |
| | P4:29,3 | Mode 6: 29.6 | |
| | P5:29,3 | Mode 7:40.8 | |
| | P6:29,3 | Mode 8: 24 | |
| | P7:29,3 | | |
| | P8: 29,3 | | |
| | P9 min (30 Hz - 150 μs): 29,3 | | |
| | P9 - EMS 1: 29,3 | | |
| | P9 max (80 Hz - 400 μs): 29,3 | | |
| | P10: 29,3 | | |
| | P11: 29,3 | | |
| | P12: 29,3 | | |
| | P13: 29,3 | | |
| P15 min (1 Hz - 50 μs): 29,3 P15 max (120 Hz - 400 μs): 29,3 | | | |
510(k) Summary
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| Maximum Output Voltage (Volts) (+/- 20 %) at 2 kΩ | P1: 58 | Mode 1: This mode cycles the following modes | Maximum output voltage of the subject device is very near to this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 58 | Mode 2: 80,8 | |
| | P3: 58 | Mode 3: 96 | |
| | P4: 58 | Mode 4: 93,6 | |
| | P5: 58 | Mode 5: 66,4 | |
| | P6: 58 | Mode 6: 66,4 | |
| | P7: 58 | Mode 7:86,4 | |
| | P8: 58 | Mode 8: 53,6 | |
| | P9 min (30 Hz - 150 μs): 58 | | |
| | P9 - EMS 1: 58 | | |
| | P9 max (80 Hz - 400 μs): 59 | | |
| | P10: 58 | | |
| | P11: 58 | | |
| | P12: 58 | | |
| | P13: 58 | | |
| | P15 min (1 Hz - 50 μs): 58 | | |
| | P15 max (120 Hz - 400 μs): 58 | | |
510(k) Summary
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| Maximum Output Voltage (Volts) (+/- 20 %) at 10 kΩ | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient from feeling an electric discharge as the attached surface diminishes. The 10 kOhm is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed | Mode 1: This mode cycles the following modes | NA |
| --- | --- | --- | --- |
| | | Mode 2: 134 | |
| | | Mode 3: 132 | |
| | | Mode 4: 108 | |
| | | Mode 5: 126 | |
| | | Mode 6: 126 | |
| | | Mode 7:129 | |
| | | Mode 8: 105 | |
510(k) Summary
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| Maximum Output Current (mA) (+/-20%) at 500 Ω calculated: I(A) = U(V) / R(Ω) with U = value #I(V) and R = 500 Ω This result is multiplied by 10^3 to obtain I in mA | P1:58,6 | Mode 1: This mode cycles the following modes | Maximum output current of the subject device is in the range or below this of the predicate device. They are under the maximum average current of 10 mA into a load of 500 ohms defined in the ANSI AAMI NS4 § 3.2.2.2. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 58,6 | | |
| | P3: 58,6 | Mode 2: 72,8 | |
| | P4: 58,6 | Mode 3: 95,2 | |
| | P5: 58,6 | Mode 4: 115,2 | |
| | P6: 58,6 | Mode 5: 59,2 | |
| | P7: 58,6 | Mode 6: 59,2 | |
| | P8: 58,6 | Mode 7:81,6 | |
| | P9 min (30 Hz - 150 μs): 58,6 | Mode 8: 48 | |
| | P9 - EMS 1: 58,6 | | |
| | P9 max (80 Hz - 400 μs): 58,6 | | |
| | P10: 58,6 | | |
| | P11: 58,6 | | |
| | P12: 58,6 | | |
| | P13: 58,6 | | |
| | P15 min (1 Hz - 50 μs): 58,6 | | |
| P15 max (120 Hz - 400 μs): 58,6 | | | |
510(k) Summary
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| Maximum Output Current (mA) (+/-20%) at 2 kΩ | P1: 29 | Mode 1: This mode cycles the following modes | Maximum output current of the subject device is very near to this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
| --- | --- | --- | --- |
| | P2: 29 | | |
| | P3: 29 | Mode 2: 40,4 | |
| | P4: 29 | Mode 3: 48 | |
| | P5: 29 | Mode 4: 46,8 | |
| | P6: 29 | Mode 5: 33,2 | |
| | P7: 29 | Mode 6: 33,2 | |
| | P8: 29 | Mode 7:43,2 | |
| | P9 min (30 Hz - 150 μs): 29 | Mode 8: 26,8 | |
| | P9 - EMS 1: 29 | | |
| | P9 max (80 Hz - 400 μs): 29,5 | | |
| | P10: 29 | | |
| | P11: 29 | | |
| | P12: 29 | | |
| | P13: 29 | | |
| | P15 min (1 Hz - 50 μs): 29 | | |
| P15 max (120 Hz - 400 μs): 29 | | | |
510(k) Summary
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| Maximum Output Current (mA) (+/-20%) at 10 kΩ | NA: The EIG monitors the impedance of each channel and stops any running program (or refuses to launch one) if the measured impedance is out of a specified range. This feature ensures a proper installation of the EIG, the cables and electrodes. If an electrode peels off, stopping the stimulation program quickly enough prevents the patient from feeling an electric discharge as the attached surface diminishes. The 10 kOhm is at the upper range and the EIG refused to launch a stimulation program, thus the measurement could not be performed | Mode 1: This mode cycles the following modes | NA |
| --- | --- | --- | --- |
| | | Mode 2: 13,4 | |
| | | Mode 3: 13,2 | |
| | | Mode 4: 10,8 | |
| | | Mode 5: 12,6 | |
| | | Mode 6: 12,6 | |
| | | Mode 7:12,9 | |
| | | Mode 8: 10,5 | |
| | | | |
| | | | |
510(k) Summary
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| Pulse Width (μs) | P1: 198
P2: 148
P3: 248
P4: 198
P5: 148
P6: 198 or 148
P7: 148
P8: modulated 98 -198
P9 min (30 Hz - 150 μs): 147.5
P9 - EMS 1: 248
P9 max (80 Hz - 400 μs): 397
P10: 148
P11: 148
P12: 58
P13: 178
P15 min (1 Hz - 50 μs): 47
P15 max (120 Hz - 400 μs): 398 | Undisclosed for each mode. Only a value for an undetermined mode. PL-029K12: 100 | These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
510(k) Summary
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| Frequency (Hz) | P1: 100,06 | Mode 1: This mode cycles the following modes | The difference of frequencies between the subject device and predicate device does not raise new types of safety or effectiveness questions because the user chooses the frequency through different kinds of programs using the mobile application and programs are using standard TENS stimulation frequencies. |
| --- | --- | --- | --- |
| | P2: 80,022 | Mode 2: 62,5 | |
| | P3: 2,0006 | Mode 3: 12,8~54,3 | |
| | P4: 100,06 | Mode 4: 1,19 | |
| | P5: 100,03 | Mode 5: 104,1 | |
| | P6: 2 or 100 | Mode 6: 104,1 | |
| | P7: 100 | Mode 7:19,8 | |
| | P8: modulated 2 - 80 | Mode 8: 156,2 | |
| | P9 min (30 Hz - 150 μs): 30 | | |
| | P9 - EMS 1: 50,02 | | |
| | P9 max (80 Hz - 400 μs): 80 | | |
| | P10: 80,02 | | |
| | P11: 80,02 | | |
| | P12: 80,06 | | |
| | P13: 10,006 | | |
| | P15 min (1 Hz - 50 μs): | | |
| | 1,0003 P15 max (120 Hz - 400 μs):120.08 | | |
| For interferential modes only: - Beat Frequency (Hz) | NA: Not interferential mode | NA: Not interferential mode | NA |
| For multiphasic waveforms only: - Symmetrical phases? Yes / No - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | Biphasic | Not publicly disclosed | Values of the predicate are not publicly available. |
| | - No, asymmetrical | | |
| | Phase 1: corresponds to the pulse width Phase 2 (discharge duration): 120 μs +/- 10 μs | | |
510(k) Summary
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actiTENS mini 510(k) Submission
| Net Charge (μC per pulse) at 500 Ω | 0 | Not publicly disclosed | For subject device, zero net charge is obtained through compensated asymmetrical biphasic waves. Predicate net charge is not publicly available but is most certainly 0 thanks to the biphasic waves. Zero net charge is safe for the patient. |
| --- | --- | --- | --- |
| Maximum Phase Charge (μC) at 500 Ω calculated: Q(C) = I(A) x d(s) with I and d values measured above. This result is multiplied by 10^6 to obtain Q in μC | P1: 11,6
P2: 8,7
P3: 14,5
P4: 11,6
P5: 8,7
P6: 8,7 to 11,6
P7: 8,7
P8: 5,7 to 11,6
P9 min (30 Hz - 150 μs): 8,6
P9 - EMS 1: 14,5
P9 max (80 Hz - 400 μs): 23,3
P10: 8,7
P11: 8,7
P12: 3,4
P13: 10,4
P15 min (1 Hz - 50 μs): 2,8 P15 max (120 Hz - 400 μs): 23,3 | Mode 1: This mode cycles the following modes
Mode 2: 14,6
Mode 3: 19
Mode 4: 23
Mode 5: 11,8
Mode 6: 11,8
Mode 7:16,3
Mode 8: 9,6 | Maximum phase charge of the subject device is very near to this of the predicate device. These technological differences between the subject and predicate device do not impact safety and effectiveness |
510(k) Summary
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actiTENS mini 510(k) Submission
| Maximum Current Density (mA/cm²) at 500 Ω calculated along Guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p13-14. Maximum current density (mA/cm²) = I (mA) x f (Hz) x d (s) / S (cm²) With I, f, d and S values measured above | P1: 0,144 | Mode 1: This mode cycles the following modes | Maximum current density of the subject device stays in the same order of magnitude as this of the predicate device (from 0,0003 mA/cm² vs 0,0003 mA/cm² up to 0,348 mA/cm² vs 0,017 mA/cm²). These values stay under 2 mA/cm². These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: 0,086 | | |
| | P3: 0,004 | Mode 2: 0,013 | |
| | P4: 0,144 | Mode 3:0,003~0,014 | |
| | P5: 0,108 | Mode 4: 0,0003 | |
| | P6: 0,003 or 0,108 | Mode 5: 0,017 | |
| | P7: 0,108 | Mode 6: 0,017 | |
| | P8: 0,003 or 0,057 | Mode 7:0,004 | |
| | P9 min (30 Hz - 150 μs): 0,032 | Mode 8: 0,021 | |
| | P9 - EMS 1: 0,090 | | |
| | P9 max (80 Hz - 400 μs): 0,231 | | |
| | P10: 0,086 | | |
| | P11: 0,086 | | |
| | P12: 0,034 | | |
| | P13: 0,013 | | |
| | P15 min (1 Hz - 50 μs): 0,0003 P15 max (120 Hz - 400 μs): 0,348 | | |
510(k) Summary
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actiTENS mini 510(k) Submission
| Maximum Power Density (mW/cm2) at 500 Ω calculated along Guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p13-14. Maximum power density (mW/cm2) = U(V) x Maximum current density (mA/cm2) with U and Maximum current density measured above | P1: 4,23 | Mode 1: This mode cycles the following modes | Maximum power density of the subject device stays in the same order of magnitude as this of the predicate device (from 0,01 mW/cm2 vs 0,02 mW/cm2 up to 10,20 mW/cm2 vs 0,68 mW/cm2). These values stay well under 0,25 W/cm2 as required by the guidance "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 1999, p 14, to reduce the risk of thermal burns. These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: 2,53 | | |
| | P3: 0,11 | Mode 2: 0,46 | |
| | P4: 4,23 | Mode 3:0,16~0,68 | |
| | P5: 3,16 | Mode 4: 0,02 | |
| | P6: 0,08 or 3,160 | Mode 5: 0,51 | |
| | P7: 3,16 | Mode 6: 0,51 | |
| | P8: 0,08 to 1,67 | Mode 7:0,18 | |
| | P9 min (30 Hz - 150 μs): 0,94 | Mode 8: 0,50 | |
| | P9 - EMS 1: 2,65 | | |
| | P9 max (80 Hz - 400 μs): 6,78 | | |
| | P10: 2,53 | | |
| | P11: 2,53 | | |
| | P12: 0,99 | | |
| | P13: 0,38 | | |
| | P15 min (1 Hz - 50 μs): 0,01 P15 max (120 Hz - 400 μs): 10,20 | | |
| Burst Mode (i.e., pulse trains) a. Pulses per burst b. Bursts per second c. Burst duration (seconds) d. Duty Cycle [Line (b) x Line (c)] | All programs except P7: NA (continuous) Burst mode for TENS functionality: P7 a: 25 b: 2 c: 0.25 d: 0.5 | NA | The additional burst mode for TENS functionality does not affect the safety and effectiveness of the device. |
510(k) Summary
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actiTENS mini 510(k) Submission
| ON Time (seconds) | P1: NA (continuous) | 3.4 ~ 20 | ON Times stays in the same order of magnitude as those of the predicate (1 to 60 s vs 3.4 to 20 s). These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: NA (continuous) | | |
| | P3: NA (continuous) | | |
| | P4: NA (continuous) | | |
| | P5: NA (continuous) | | |
| | P6: NA (continuous) | | |
| | P7: NA (burst) | | |
| | P8: NA (continuous) | | |
| | P9 min (30 Hz - 150 | | |
| | μs):1 P9 - EMS 1:5 | | |
| | P9 max (80 Hz - 400 μs): | | |
| | 60 P10: NA | | |
| | (continuous) P11: NA | | |
| | (continuous) P12: NA | | |
| | (continuous) P13: NA | | |
| | (continuous) | | |
| | P15 min (1 Hz - 50 μs): NA | | |
| (continuous) | | | |
| P15 max (120 Hz - 400 μs): NA | | | |
| (continuous) | | | |
510(k) Summary
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| OFF Time (seconds) | P1: NA (continuous) | 1 ~ 2.5 | OFF Times stays in the same order of magnitude as those of the predicate (1 to 60 s vs 1 to 2.5 s) These technological differences between the subject and predicate device do not impact safety and effectiveness. |
| --- | --- | --- | --- |
| | P2: NA (continuous) | | |
| | P3: NA (continuous) | | |
| | P4: NA (continuous) | | |
| | P5: NA (continuous) | | |
| | P6: NA (continuous) | | |
| | P7: NA (burst) | | |
| | P8: NA (continuous) | | |
| | P9 min (30 Hz - 150 μs): 60 | | |
| | P9 - EMS 1: 12 | | |
| | P9 max (80 Hz - 400 μs): | | |
| | 1 P10: NA (continuous) | | |
| | P11: NA (continuous) | | |
| | P12: NA (continuous) | | |
| | P13: NA (continuous) | | |
| | P15 min (1 Hz - 50 μs): NA (continuous) | | |
| | P15 max (120 Hz - 400 μs): NA (continuous) | | |
| Additional features | NA | NA | NA |
| Number of output channels - Synchronous or Alternating? - Method of Channel Isolation: | 2 - Alternating - Mechanical | 1 - Not publicly disclosed - Not publicly disclosed | The addition of a second channel does not impact the safety or effectiveness of the device because each channel operates independently and within the same electrical output specifications as the predicate. |
510(k) Summary
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actiTENS mini 510(k) Submission
| Regulated Current or Regulated Voltage? | Regulated current | Regulated voltage | . Both approaches deliver therapeutic stimulation within safe and effective ranges. This difference in regulation method does not alter the waveform, treatment parameters, or clinical effect, and therefore does not impact safety or effectiveness. |
| --- | --- | --- | --- |
510(k) Summary
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| Software/Firmware/Microprocessor Control? | Yes, software control | Not publicly disclosed | Values of the predicate are not publicly available. |
| --- | --- | --- | --- |
| Automatic Overload Trip? | No, overload not possible by design | Not publicly disclosed | Values of the predicate are not publicly available. |
| Automatic No-Load Trip? | Yes, verification step during program launch and stimulation stops in case of detection of no-load. | Not publicly disclosed | Values of the predicate are not publicly available. |
| Automatic Shut Off? | Yes, the generator turns off after 10 minutes of no activity. | Not publicly disclosed | Values of the predicate are not publicly available. |
| Patient Override Control? | Yes, through the mobile app | Not publicly disclosed | Values of the predicate are not publicly available. |
| Timer Range (minutes) | Session duration:10 -720, adjustable via the mobile app | Not publicly disclosed | Values of the predicate are not publicly available. |
| Compliance with Voluntary Standards? | Yes (specified at the end of this document*) | Yes | NA: both devices are compliant with voluntary standards |
| Compliance with 21 CFR 898? | Yes | Yes | NA: No difference |
| Weight | ~ 60 g | Not publicly disclosed | Values of the predicate are not publicly available. |
| Dimensions (mm) [W x H x D] | 92 mm x 15 mm x 56mm | Not publicly disclosed | Values of the predicate are not publicly available. |
| Indicator Display:
- ON/OFF status?
- Low battery?
- Current level? | Yes:LED indicator / mobile app
Yes:Indicated on the mobile app
Yes:Indicated on the mobile app | Not publicly disclosed | Values of the predicate are not publicly available. |
510(k) Summary
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| Performance Testing | The following benchtop performance testing was performed:
**Transportation Testing:**
- Transportation test report
**Self-adhesive strips wearability:**
- Wearability test report of the self-adhesive strips
**Interoperability:**
- Validation report of the system
**Usability Testing:**
- Validation plan
- Usability Engineering File Usability Engineering File – final validation report | Not publicly disclosed | Performance testing carried out on the predicate device is not disclosed. |
| --- | --- | --- | --- |
510(k) Summary
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* Compliance with voluntary standards:
- ISO 14971:2019
- ISO 15223-1:2021
- IEC 60601-1:2005+A1:2012+A2:2020
- IEC 62304:2006 / A1:2015
- IEC 62366-1:2015 + A1:2020
- UN38.3
- ISO 20417:2021
- ISO 17664-2:2021
- IEC 60601-1-2:2014 + A1:2020
- IEC 60601-1-6:2010+A1:2013 + A2:2020
- IEC 60601-1-11:2015 + A1:2020
- IEC 60601-2-10:2012 + A1:2016 + A2:2023
- ISO 10993-1:2018
- ISO 10993-5:2009
- ISO 10993-10:2010
- ISO 10993-12:2012
- ANSI/HIBCC 2.6:2016
- ASTM F2503-23e1
- AAMI ANSI NS4
- UL 1642 6th Edition Lithium Batteries
- ASTM D4169-23
- UL 94 ed.7-2023
- UL969 ed. 5-2017
- UL 796 Ed. 12-2020
- CAN/CSA-C22.2 No. 0.17"
- ANSI/UL248-1 Ed.4
- ANSI/UL 497B Ed.4
- UL 2900-2-1
- IEC/TR 60601-4-2
- ASTM F1980-16
- AIM Standard 7351731 Rev. 3.00
- AAMI TIR69:2017/(R2020)
- IEEE ANSI USEMCSC C63.27-2021
510(k) Summary
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# VIII. BRIEF DISCUSSION OF NONCLINICAL TESTS
The following nonclinical testing was provided in support of the substantial equivalence determination.
## Biocompatibility Testing
- Cytotoxicity Testing (MEM Elution) - ISO 10933-5
- Sensitization Testing (Guinea Pig Maximization) - ISO 10933-10
- Irritation Testing (Intracutaneous Irritation) - ISO 10933-23
## Sterilization Validation
Not applicable, because subject device and components are non-sterile and components are not intended to be sterilized by the user.
## Shelf-life
Wearability test report of the self-adhesive strips
## Software Validation, Cybersecurity, Wireless Safety, and Interoperability
- IEC 62304-1
- Cybersecurity testing
- IEEE/ANSI C63.27-2021 Wireless Coexistence
## Electrical Safety & EMC Testing
- IEC 60601-2-10
- IEC 60601-1-11
- IEC 60601-1-6
- IEC 60601-1-2
- IEC 60601-1
## Performance Testing (non-clinical benchtop):
- Transportation Testing
- Output waveforms
- Usability Documentation
## Performance Testing (animal studies):
Not Applicable, because the device does not require animal studies to demonstrate performance.
# IX. BRIEF DISCUSSION OF CLINICAL TESTS
Not Applicable, because the device does not require clinical studies to demonstrate performance.
# X. CONCLUSIONS FROM NONCLINICAL AND CLINICAL TESTS
The subject device, actiTENS mini, has the same indications for use when compared with the predicate devices (K202159 and K182203). The subject device and the predicate devices have similar technological characteristics. Non-clinical benchtop testing shows that the subject device is substantially equivalent in terms of safety and effectiveness when compared with the predicate device and performs as well as the predicate.
510(k) Summary
