actiTENS

K202159 · Sublimed · GZJ · Dec 22, 2020 · Neurology

Device Facts

• Record ID: K202159
• Device Name: actiTENS
• Applicant: Sublimed
• Product Code: GZJ · Neurology
• Decision Date: Dec 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. · 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

actiTENS is a compact, wearable transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS) for chronic pain management and muscle therapy. Device consists of an electrical impulse generator, rechargeable lithium-ion battery, and disposable electrodes. Operated via a downloadable iPhone mobile app for program selection and manual intensity adjustment (0.5mA increments). Used by patients at home or by medical professionals in clinical settings. Device delivers biphasic, asymmetric electrical stimulation waveforms to targeted nerves/muscles. Integrated impedance monitoring automatically stops stimulation if electrodes peel off or impedance is out of range to prevent discomfort. Benefits include non-invasive pain relief, muscle rehabilitation, and prevention of venous thrombosis. Prescription-only device.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via benchtop performance testing, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), and software verification/validation (IEC 62304).

Technological Characteristics

Rechargeable lithium-ion battery-powered electrical stimulator. Biphasic, asymmetric waveforms. Connectivity via mobile app (iPhone). Impedance monitoring for safety. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, IEC 62366-1, ASTM D4169-16, UL 1642, IEC 62133-2. Non-sterile.

Indications for Use

Indicated for patients 22 years and older for symptomatic relief of chronic intractable pain, post-surgical/post-trauma acute pain, pain from muscle strain, arthritis, muscle spasms, disuse atrophy, local blood flow increase, muscle re-education, range of motion maintenance, and prevention of post-surgical venous thrombosis.

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

• JKH Stimulator Plus (K182203)

Submission Summary (Full Text)

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December 22, 2020

Sublimed % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K202159

Trade/Device Name: actiTENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, NGX, NYN, IPF Dated: July 30, 2020 Received: August 3, 2020

Dear Robert 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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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# Indications for Use

510(k) Number (if known) K202159

Device Name actiTENS

#### Indications for Use (Describe)

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.

· 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) | <div> <span> </span> </div> |
|----------------------------------------------|-----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> </span> </div> |

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

- -SUBMITTER SUBLIMED 137 rue de Mayoussard Moirans, F-38430 France Tel: [phone]
Contact Person: Corinne Bulteau Date Prepared: December 22, 2020

| II. DEVICE | |
|------------------------------|------------------------------------------------------------|
| Trade/Device Name: | actiTENS |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Regulation: | 21 CFR § 882.5890 |
| Regulatory Class: | Class II |
| Product Classification Code: | GZJ, NGX, NYN, IPF |

| III. PREDICATE DEVICE | |
|-------------------------|---------------------|
| Predicate Manufacturer: | JKH USA, LLC |
| Predicate Trade Name: | JKH Stimulator Plus |
| Predicate 510(k): | K182203 |

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.

The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.

The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.

The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.

The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.

The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.

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It is available for prescription only.

#### V. INDICATIONS FOR USE

#### 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.

· 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.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

The table below provides a comparison of indications for use and technological characteristics between the subject device and the predicate device in order to demonstrate substantial equivalence:

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# Comparison with Predicate Device:

Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203).

| Feature | actiTENS | JKH Stimulator Plus -<br>K182203 | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | actiTENS is intended to be<br>used as:<br>• Transcutaneous Electrical<br>Nerve Stimulator (TENS),<br>used for the following<br>indications:<br>- Symptomatic relief and<br>management of chronic,<br>intractable pain<br>- Adjunctive treatment for<br>post-surgical and post-trauma<br>acute pain<br>- Temporary relief of pain<br>associated with sore and<br>aching muscles due to strain<br>from exercise or normal<br>household and work activities<br>- Relief of pain associated<br>with arthritis<br>Programs P1, P2, P3, P4, P5,<br>P6, P7, P8, P10, P11, P12 and<br>P13 correspond to TENS<br>mode.<br>• Electrical Muscle<br>Stimulation (EMS), used for<br>the following indications: | Over-the-Counter Use:<br>TENS (Modes 1, 2, 4, 6,<br>8):<br>PL-029K12 and PL-<br>029K13 are used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, arm,<br>and leg, due to strain from<br>exercise or normal household<br>work activities. PL-0219K12<br>and PL-<br>029K13 are also intended<br>for symptomatic relief an<br>management of chronic,<br>intractable pain and relief of<br>pain associated with<br>arthritis.<br>The device of PL-029K12<br>may be used during sleep.<br>The device of PL-029K12 is<br>labeled for use only with its<br>own compatible electrodes.<br>PMS (also called EMS,<br>Modes 1, 3, 7):<br>PL-029K12 and PL- | The subject device is not<br>intended for OTC use, and<br>the prescription use of the<br>subject device is identical to<br>the indications of the<br>predicate model PL-<br>029K12. |

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| - Temporary relaxation of<br>muscle spasms | 029K13 are also intended to<br>temporarily increase local<br>blood circulation in the<br>healthy muscles of lower<br>extremities. |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| - Prevent or retard disuse<br>atrophy | Heating:<br>The device of PL-029K13<br>is intended for temporary<br>relief of minor aches and<br>pains. |
| - Increase of local blood flow<br>in the treatment area | Prescription Use:<br>PL-029K12 and PL-<br>029K13 are intended for<br>the following use: |
| - Re-educate muscles | -Symptomatic relief and<br>management of chronic,<br>interactable pain |
| - Maintain or increase the<br>range of motion | -Adjunctive treatment for<br>post-surgical and post-<br>trauma acute pain |
| - Prevention of venous<br>thrombosis of the calf<br>muscles immediately after<br>surgery | -Relief of pain associated<br>with arthritis |
| Program P9 corresponds to<br>EMS mode. | -Temporary relaxation of<br>muscle spasm |
| | -Prevention or retardation of<br>disuse atrophy |
| | -Muscle re-education |
| | -Maintaining or increasing<br>range of motion |
| | -Increase of local blood<br>flow in the treatment area |
| | -Prevention of post-<br>surgical venous<br>thrombosis through |

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| | | immediate stimulation of<br>calf muscles | |
|-----------------------------------------|------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription or OTC | Prescription | OTC and Prescription | The subject device does not<br>include OTC indications,<br>but this eliminates the risks<br>associated with OTC use. |
| Power Source(s) | Rechargeable | Rechargeable or non-<br>rechargeable battery | The subject device is<br>limited to use with the<br>rechargeable lithium-ion<br>battery, but this does not<br>introduce any new risks. |
| Compliance with Voluntary<br>Standards? | Yes | Yes | Same |
| Compliance With 21 CFR<br>898? | Yes | Yes | Same |
| Functions and design | Electrical stimulation | Electrical stimulation and<br>heat | The subject device does not<br>include the IRT product<br>classification, and this<br>eliminates the risks<br>associated with that<br>function. |
| Maximum skin temperature | N/A | 43°C | The subject device does not<br>include the IRT product<br>classification and does not<br>provide heat |

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| | | actiTENS | JKH Stimulator Plus – K182203 | Comparison |
|-------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum output<br>voltage (Volts+/- 20%) at<br>500Ω | P1 | | 30.2 PL- 029K12: 57.6 | Maximum output voltage of the subject<br>device is in the range or below this of the<br>predicate device. These technological<br>differences between the subject and<br>predicate device do not raise new safety<br>and effectiveness questions |
| | P2 | | 30.2 PL- 029K13: 46.0 | |
| | P3 | | 30 | |
| | P4 | | 30.2 | |
| | P5 | | 30.2 | |
| | P6 | | 30 | |
| | P7 | | 30.2 | |
| | P8 | | 30.2 | |
| | P9 | | 29.5 | |
| | P10 | | 29.1 | |
| | P11 | | 29.3 | |
| | P12 | | 30.2 | |
| | P13 | | 30.2 | |
| Maximum output<br>voltage (Volts+/- 20%) at<br>2KΩ | P1 | | 57.9 PL- 029K12: 96.0 | Maximum output voltage of the subject<br>device is in the range or below this of the<br>predicate device. These technological<br>differences between the subject and<br>predicate device do not raise new safety<br>and effectiveness questions |
| | P2 | | 57.9 PL- 029K13: 90.4 | |
| | P3 | | 57.9 | |
| | P4 | | 57.9 | |
| | P5 | | 57.9 | |
| | P6 | | 57.9 | |
| | P7 | | 57.9 | |
| | P8 | | 57.9 | |
| | P9 | | 57.9 | |
| | P10 | | 57.9 | |
| | P11 | | 57.9 | |
| | P12 | | 57.9 | |
| | P13 | | 57.9 | |
| Maximum output<br>voltage (Volts+/- 20%) at<br>$10KΩ$ | P1<br>P2<br>P3<br>P4<br>P5<br>P6<br>P7<br>P8<br>P9<br>P10<br>P11<br>P12<br>P13 | N/A | PL-029K12: 134<br>PL-029K13: 124 | The EIG monitors the impedance of each<br>channel and stop any running program (or<br>refuse to launch one) if the measured<br>impedance is out of a specified range. This<br>feature ensures a proper installation of the<br>EIG, the cables and electrodes. If an<br>electrode peels off, stopping the stimulation<br>program quickly enough prevents the<br>patient from feeling an electric discharge as<br>the attached surface diminishes. The 10<br>$kOhm$ is at the upper range and the EIG<br>refused to launch a stimulation program,<br>thus the measurement could not be<br>performed |
| Maximum output<br>current(mA+/- 20%) at<br>$500Ω$ | P1<br>P2<br>P3<br>P4<br>P5<br>P6<br>P7<br>P8<br>P9<br>P10<br>P11<br>P12<br>P13 | 60.4<br>60.4<br>60<br>60.4<br>60.4<br>60<br>60.4<br>60.4<br>59<br>58.2<br>58.6<br>60.4<br>60.4 | 60.4 PL-029K12: 115.2<br>60.4 PL-029K13: 92.0 | Maximum output current of the subject<br>device is in the range or below this of the<br>predicate device. These technological<br>differences between the subject and<br>predicate device do not raise new safety<br>and effectiveness questions |
| Maximum output<br>current(mA+/- 20%) at<br>2KΩ | P1 | 28.95 | PL-029K12: 48.0 | Maximum output current of the subject<br>device is in the range or below this of the<br>predicate device. These technological<br>differences between the subject and<br>predicate device do not raise new safety<br>and effectiveness questions |
| | P2 | 28.95 | PL-029K13: 45.2 | |
| | P3 | 28.95 | | |
| | P4 | 28.95 | | |
| | P5 | 28.95 | | |
| | P6 | 28.95 | | |
| | P7 | 28.95 | | |
| | P8 | 28.95 | | |
| | P9 | 28.95 | | |
| | P10 | 28.95 | | |
| | P11 | 28.95 | | |
| | P12 | 28.95 | | |
| | P13 | 28.95 | | |
| Maximum output<br>current(mA+/- 20%) at<br>10kΩ | P1 | N/A | PL-029K12: 13.4 | The EIG monitors the impedanceof each<br>channel and stop any running program (or<br>refuse to launch one) if the measured<br>impedance is out of a specified range. This<br>feature ensures a proper installation of the<br>EIG, the cables and electrodes. If an<br>electrode peels off, stopping the stimulation<br>program quickly enough prevents the<br>patient from feeling an electric discharge as<br>the attached surface diminishes. The 10<br>kOhm is at the upper range and the EIG<br>refused to launch a stimulation program,<br>thus the measurement could not be<br>performed |
| | P2 | | PL- 029K13: 12.4 | |
| | P3 | | | |
| | P4 | | | |
| | P5 | | | |
| | P6 | | | |
| | P7 | | | |
| | P8 | | | |
| | P9 | | | |
| | P10 | | | |
| | P11 | | | |
| | P12 | | | |
| | P13 | | | |
| | P1 | 197.5 | | |
| Pulse Width (µSec) | P2 | 147 PL-029K12: 100 | | These technological differences between<br>the subject and predicate device do not<br>raise new safety and effectiveness<br>questions |
| | P3 | 247.5 PL-029K13: 92 | | |
| | P4 | 197.5 | | |
| | P5 | 147.5 | | |
| | P6 | 200 or 147 | | |
| | P7 | 147.5 | | |
| | P8 | modulated 100-200 | | |
| | P9 | 247.5 | | |
| | P10 | 147.5 | | |
| | P11 | 147.5 | | |
| | P12 | 57.5 | | |
| | P13 | 177.5…