POCKET TENS (EP-300)

K242815 · Hivox Biotek, Inc. · NUH · Dec 17, 2024 · Neurology

Device Facts

• Record ID: K242815
• Device Name: POCKET TENS (EP-300)
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: Dec 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Device Story

Pocket TENS (EP-300) is a battery-powered (CR2032 3V) self-adhesive transcutaneous electrical nerve stimulator (TENS) for home use. Device delivers electrical stimulation to nerves via skin to provide non-pharmacological pain relief. User places self-adhesive gel pads on pain sites, powers on device, and selects from 15 intensity levels for a 20-minute treatment session. Device includes pocket storage rack for electrodes and stimulator. Healthcare provider involvement is recommended for initial symptom assessment and instruction on self-treatment regime. Output affects pain perception through electrical nerve stimulation. Benefits include temporary relief of muscle soreness and aching.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

ABS plastic enclosure; CR2032 3V battery power; regulated voltage output; 15 intensity levels; 20-minute timer; self-adhesive gel pads (75mm x 48mm). Complies with ISO 10993 (biocompatibility), IEC 62304 (software), ISO 14971 (risk management), IEC 60601-1 (electrical safety), and IEC 60601-2-10 (nerve/muscle stimulators).

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities in home settings.

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

• HIVOX OTC Electrical Stimulator (K171803)
• HIVOX Electric Stimulator OTC TENS, Rapid Relief™ Pennypad PP-904 (K140650)

Submission Summary (Full Text)

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December 17, 2024

Hivox Biotek Inc. Leslie Peng Senior Product Manager 5F., No. 123, Xingde Rd., Sanchong District New Taipei City, 24158 Taiwan

#### Re: K242815

Trade/Device Name: Pocket Tens (EP-300) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 6, 2024 Received: September 18, 2024

Dear Leslie Peng:

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.

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).

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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 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-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 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 Rue"). 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-device-advicecomprehensive-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-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).

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Sincerely,

# Robert Kang -S

for Pamela Scott, MS 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

Submission Number (if known)

K242815

Device Name

POCKET TENS (EP-300)

#### Indications for Use (Describe)

POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY

#### 1. Type of Submission Traditional

- 2. Date of Summary December 16, 2024
- HIVOX BIOTEK INC. 3. Submitter Address: 5F., No. 123, Xingde Rd., Sanchong District, New Taipei City 241, Taiwan, R.O.C. Phone: [phone] Fax: [phone] Contact: Leslie Peng ([e-mail])

### 4. Identification of the Subject Device

| Proprietary name: | POCKET TENS |
|-------------------------|------------------------------------------------------------|
| Model: | EP-300 |
| Regulation number: | 21 CFR 882.5890 |
| Regulation description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH |
| Device class: | II |

#### 5. Identification of the Predicate Device #1

| 510(k) number: | K171803 |
|------------------------------------|------------------------------------------------------------|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary name: | HIVOX OTC Electrical Stimulator |
| Model: | SEM44-1 |
| Primary Regulation<br>number: | 21 CFR 882.5890 |
| Primary Regulation<br>description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH, NGX |
| Device class: | II |

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### 6. Identification of the Predicate Device #2

| 510(k) number: | K140650 |
|-------------------------|----------------------------------------------------------------------|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary name: | HIVOX Electric Stimulator OTC TENS, Rapid Relief™<br>Pennypad PP-904 |
| Model: | PP-904 |
| Regulation number: | 21 CFR 882.5890 |
| Regulation description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH |
| Device class: | II |

### 7. Device Description

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

### 8. Intended Use / Indications for Use

POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

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#### 9. Substantial Equivalence Comparison

Refer to section 12 for complete comparison table.

#### 10. Non-clinical Testing

A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:

- Shelf life
- Gel pad lifetime
- Biocompatibility
- Biological evaluation (ISO 10993-1:2018) -
- -In Vitro Cytotoxicity Test (ISO 10993-5:2009)
- Skin Sensitization Study (ISO 10993-10:2021, ISO 10993-10:2010) |
- -Skin Irritation Study (ISO 10993-23:2021, ISO 10993-10:2010)
- Software validation
- IEC 62304:2006+A1:2015 -
- -ISO 14971:2019
- ISO TR 24971:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- EMC and electrical safety ●
- -IEC 60601-1-2:2014+A1:2020
- -IEC TR 60601-4-2:2016
- ANSI/AAMI ES60601-1:2005+A2:2021 -
- IEC 60601-1-11:2015+A1:2020 -
- IEC 60601-2-10:2012+A1:2016 —
- -IEC 60086-4:2019
- Performance verification
- Guidance Document for Powered Muscle Stimulator 510(K)s. (June 9, -1999)
- Output waveform validation ●
- Impedance validation
- Usability
- IEC 60601-1-6:2010+A2:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- ANSI/AAMI/IEC 62366-1:2015+A1:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices.

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### 11. Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

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# 12. Substantial Equivalence Comparison

The subject device, POCKET TENS (EP-300), was compared to the predicate devices in the table below:

| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510(k) number | K242815 | K171803 | K140650 | | |
| Device name | POCKET TENS | HIVOX OTC Electrical<br>Stimulator | HIVOX Electric Stimulator OTC<br>TENS, Rapid Relief™ Pennypad<br>PP-904 | N/A | |
| Model | EP-300 | SEM44-1 | PP-904 | | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | | |
| Intended Use | POCKET TENS (EP-300)<br>which is home used device<br>is designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, back, upper<br>extremities (arm) and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work | The device is designed to be<br>used for temporary relief of<br>pain associated with sore and<br>aching muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm), lower<br>extremities (leg), abdomen and<br>bottom due to strain from<br>exercise or normal household<br>work activities. | The HIVOX Electric Stimulator<br>OTC TENS, Rapid Relief™<br>Pennypad PP-904, is indicated for<br>temporary relief of pain associated<br>with sore and aching muscles in<br>the upper and lower extremities<br>(arm and/or leg), and lower back<br>due to strain from exercise or<br>normal household and work<br>activities. | | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination | |
| | activities. | | | | |
| FDA product code | NUH | NUH, NGX | NUH | All predicates have NUH product<br>code | |
| Prescription or OTC | OTC | OTC | OTC | Identical to predicate devices | |
| Basic unit characteristics | | | | | |
| Power source(s) | CR2032 Lithium 3V | 4.5V (batteries, 3x1.5V AAA) | CR2032 Lithium 3V | Identical to Predicate device #2 | |
| Function and design | Electrical stimulation | Electrical stimulation | Electrical stimulation | Identical to predicate devices | |
| Number of output modes | TENS:1 | TENS:15 | TENS:1 | Identical to Predicate device #2 | |
| Number of<br>output<br>channels | Synchronous<br>or<br>Alternating? | Single Channel | Two Channels<br>(Synchronous) | Single Channel | Identical to Predicate device #2 |
| | Method of<br>channel<br>isolation | N/A | By electrical circuit and software | N/A | Identical to Predicate device #2 |
| Regulated current or<br>regulated voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Identical to predicate devices | |
| Software/Firmware/<br>Microprocessor Control? | Yes | Yes | Yes | Identical to predicate devices | |
| Automatic overload trip? | Yes | Yes | Yes | Identical to predicate devices | |
| Automatic no-load trip? | Yes | Yes | Yes | Identical to predicate devices | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination | |
| Automatic shut off? | Yes | Yes | Yes | Identical to predicate devices | |
| Patient override control? | Yes | Yes | Yes | Identical to predicate devices | |
| Indicator<br>display | On/off<br>status? | No | Yes | No | Identical to Predicate device #2 |
| | Low battery? | No | Yes | No | Identical to Predicate device #2 |
| | Voltage/<br>current<br>level? | No | Yes | No | Identical to Predicate device #2 |
| Timer range (minutes) | 20 | 5-100 | 20 | Identical to Predicate device #2 | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination | |
| Compliance with<br>voluntary standards? | ISO 10993-1:2018<br>ISO 10993-5:2009<br>ISO 10993-10:2010<br>ISO 10993-10:2021<br>ISO 10993-23:2021<br>IEC 62304:2006+A1:2015<br>ISO 14971:2019<br>ISO TR 24971:2020<br>IEC 60601-1-2:2014<br>+A1:2020<br>IEC TR 60601-4-2:2016<br>ANSI/AAMI ES60601-1:<br>2005+A2:2021<br>IEC 60601-1-11:2015<br>+A1:2020<br>IEC 60601-2-10:2012<br>+A1:2016<br>IEC 60086-4:2019<br>IEC 60601-1-6:2010<br>+A2:2020<br>ANSI/AAMI/IEC 62366-1:<br>2015+A1:2020 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 10993-5/10 | IEC/EN 60601-1<br>IEC/EN 60601-1-2<br>IEC/EN 60601-2-10 | The subject device complies with<br>the latest standards. | |
| Compliance with 21 CFR | Yes | Yes | Yes | Identical to predicate devices | |
| Comparison item | | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination |
| 898? | | | | | |
| Weight | | Main device<br>(including a set of pad): 35.6 g<br>Gel pads (2 pieces): 9.4 g<br>Battery: 3.0 g | 89 g<br>(including belt clip, without<br>batteries),<br>123 g<br>(including belt clip and batteries) | 13.7 g (excluded battery) | The differences from weight would<br>not raise concern in safety or<br>effectiveness as predicate devices |
| Dimensions<br>[W × H × D] | | Approx.<br>Main device:<br>66.8 × 35.0 × 10.6 mm<br>Pad: 99.5 × 62.0 × 1.0 mm<br>Wire: 391.0 mm | Approx.<br>132 × 63 × 29.5 mm<br>(including belt clip) | Approx.<br>113 × 70 × 10 mm | The differences from dimension<br>would not raise concern in safety<br>or effectiveness as predicate<br>devices |
| Housing materials and<br>construction | | ABS plastic enclosure | ABS Plastic enclosure | ABS Plastic enclosure | Identical to predicate devices |
| Output specifications | | | | | |
| Waveform | | Biphasic, Symmetrical | Biphasic, Symmetrical | Monophasic with reversing polarity<br>each phase | Identical to Predicate device #1 |
| Shape | | Rectangular | Rectangular | Rectangular | Identical to predicate devices |
| Maximum<br>output | @ 500 Ω | 50V for both phases, peak of<br>25V for each phase | 100V peak-to-peak, 50V peak for<br>each phase | 30V peak monophasic | Refer to Section 13 for substantial<br>equivalence |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial<br>Equivalence Determination | |
| voltage<br>(Vp-p, ±10%) | @ 2 kΩ<br><br>92<br><br>@ 10 kΩ<br><br>101 | 180<br><br>250 | 89.6<br><br>96 | | |
| Maximum<br>output<br>current<br>(mAp-p, ±10%) | @ 500 Ω<br><br>100mA peak-to-peak, 50mA peak<br><br>@ 2 kΩ<br><br>37.5<br><br>@ 10 kΩ<br><br>10.1 | 200<br><br>90<br><br>25 | 60mA peak<br><br>44.8<br><br>9.6 | Refer to Section 13 for substantial<br>equivalence | |
| Pulse Width (μs) | 50mA x 0.4mSec = 20 μC | 50-450 | 200 | Refer to Section 13 for substantial<br>equivalence | |
| Frequency (Hz) | 4, 6 and 50 | 1-150 | 2, 5 and 40 | Refer to Section 13 for substantial<br>equivalence | |
| Net charge<br>(μC per pulse @ 500Ω) | 0 | 0.001 | 0.2304 | Refer to Section 13 for substantial<br>equivalence | |
| Maximum phase charge<br>(μC @ 500Ω) | 20 | 0.045 = 45 μC | 60mA x 0.2mSec = 12 μC | Refer to Section 13 for substantial<br>equivalence | |
| Maximum average current<br>(mA @ 500Ω) | 3.46 | 13.5 | 2.303 | Refer to Section 13 for substantial<br>equivalence | |
| Electrode conductive<br>surface area (cm²) | $31.04 cm²×2 (=62.08 cm²)$ | $20.25 cm²x4 (=81cm²)$…