HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

K203574 · Hivox Biotek, Inc. · NUH · Mar 10, 2021 · Neurology

Device Facts

• Record ID: K203574
• Device Name: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: Mar 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HIVOX OTC Electrical Stimulator, EM59-1 TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. SH: This function is designed to be used for temporary relief of minor aches and pains. HIVOX OTC Electrical Stimulator, EM59-2 TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities. EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. SH: This function is designed to be used for temporary relief of minor aches and pains.

Device Story

OTC electrostimulation device; models EM59-1 (TENS, SH) and EM59-2 (TENS, EMS, SH). Inputs: user-selected pre-set or custom stimulation programs. Operation: two independent output channels deliver biphasic electrical pulses via four self-adhesive electrode gel pads; includes superficial heat (SH) function. Used by patients in home/non-clinical settings for pain relief, muscle revitalization, and fitness. Output: electrical stimulation and heat to target tissues. Healthcare provider role: none (OTC). Benefit: temporary pain relief and improved muscle performance.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility, software validation, electromagnetic compatibility, electrical safety, and usability testing.

Technological Characteristics

Materials: ABS plastic enclosure, self-adhesive electrode gel pads (K182111), PET, sponge, PCB. Energy: 3.7V rechargeable Li-ion battery. Output: 2 independent channels, biphasic waveform, 1-150Hz frequency, 50-450µs pulse width. Max temp 43°C. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993, ASTM F1980. Software: Microprocessor-controlled with automatic overload/no-load trip and shut-off.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, upper/lower extremities due to exercise or household strain; minor aches and pains; and stimulation of healthy muscles to improve/facilitate muscle performance.

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

• Electrical Pulse Stimulator (K162517)
• HIVOX OTC Electrical Stimulator (K190347)

Submission Summary (Full Text)

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March 10, 2021

Hivox Biotek Inc. Ruby Lu Regulatory Affairs Specialist 5F, No. 123, Xingde Road, Sanchong District, New Taipei City, 241 Taiwan

Re: K203574

Trade/Device Name: HIVOX OTC Electrical Stimulator, EM59-1, HIVOX OTC Electrical Stimulator, EM59-2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: November 30, 2020 Received: December 7, 2020

Dear Ruby Lu:

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,

Pamela Scott 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K203574

Device Name

HIVOX OTC Electrical Stimulator (EM59-1, EM59-2)

Indications for Use (Describe)

HIVOX OTC Electrical Stimulator, EM59-1

TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulator, EM59-2

TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household work activities.

EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

SH: This function is designed to be used for temporary relief of minor aches and pains.

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 |
|-----------------------|-----------------------------------------------|
| 510(k) Number | K203574 |
| 2. Date of Summary | Mar. 2, 2021 |
| 3. Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., New |
| | Taipei City 24158, Taiwan, R.O.C. |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Ruby Lu |
| | ([e-mail]) |

# 4. Identification of the Subject Device

| 510(k) number | K203574 |
|------------------------------|------------------------------------------------------------------|
| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
| Models: | EM59-1, EM59-2 |
| Classification product code: | NUH |
| Subsequent product code: | NGX, IRT |
| Regulation number: | 1) 882.5890 |
| | 2) 890.5850 |
| | 3) 890.5740 |
| Regulation description: | 1) Transcutaneous electrical nerve stimulator for<br>pain relief |
| | 2) Powered muscle stimulator |
| | 3) Power heating pad |
| Review panel: | 1) Neurology |
| | 2) Physical Medicine |
| | 3) Physical Medicine |
| Device class: | II |

# 5. Identification of the Predicate Device #1

| 510(k) number: | K162517 |
|------------------------------|-----------------------------|
| Proprietary/Trade name: | Electrical Pulse Stimulator |
| Models: | PL-029K13 |
| Classification product code: | NUH, NGX, NYN, IRT |
| Regulation number: | 882.5890 |

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| Regulation description: | Transcutaneous electrical nerve stimulator for pain<br>relief |
|-------------------------|---------------------------------------------------------------|
| Review panel: | Neurology |
| Device class: | II |

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

| 510(k) number: | K190347 |
|------------------------------|------------------------------------------------------------------|
| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
| Models: | EM49-1, EM49-2 |
| Classification product code: | NUH |
| Subsequent product code: | NGX |
| Regulation number: | 1) 882.5890 |
| | 2) 890.5850 |
| Regulation description: | 1) Transcutaneous electrical nerve stimulator for<br>pain relief |
| | 2) Powered muscle stimulator |
| Review panel: | 1) Neurology |
| | 2) Physical Medicine |
| Device class: | II |

## 7. Intended Use / Indications for Use of the Device

HIVOX OTC Electrical Stimulator, EM59-1

TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulator, EM59-2

TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.

EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

SH: This function is designed to be used for temporary relief of minor aches and pains.

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# 8. Device Description

HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the

electrostimulation device category.

EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:

(1) Electrical stimulation of nerve tracts (TENS)

(2) Electrical stimulation of muscle tissue (EMS)

(3) Superficial heat (SH)

Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.

# 9. 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 (ASTM F1980-16)
- Biocompatibility (ISO 10993-1 Edition 4.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0)
- Software validation (IEC 62304 Edition 1.1)
- Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1)
- Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999)
- Usability test (IEC 60601-1-6 Edition 3.1 and IEC 62366-1 Edition 1.0)

All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (EM59-1, EM59-2), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.

## 10. Clinical Testing

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

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### 11. Substantial Equivalence Comparison

The subject device, HIVOX OTC Electrical Stimulator (EM59-1, EM59-2), was compared to a predicate device and reference device respectively in the tables below:

| Comparison item | Subject device | | Predicate device #1 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K203574 | | K162517 |
| Device Name | HIVOX OTC Electrical<br>Stimulator | | Electronic Pulse<br>Stimulator |
| Model | EM59-1 | EM59-2 | PL-029K13 |
| Manufacturer | HIVOX BIOTEK INC. | | JKH Health Co., Ltd. |
| Intended Use | EM59-1:<br>TENS: This function is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm)<br>and lower extremities<br>(leg) due to strain from<br>exercise or normal<br>household work activities.<br>SH: This function is<br>designed to be used for<br>temporary relief of minor<br>aches and pains.<br>EM59-2:<br>TENS: This function is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm) | | TENS Mode<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, arm and leg<br>due to strain from exercise<br>or normal household and<br>work activities.<br>It is also intended for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis.<br>PMS Mode<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. To<br>be used for the<br>improvement of muscle<br>tone and firmness, and for<br>strengthening muscles in<br>the arm, abdomen, legs, |
| Prescription or OTC | | OTC | OTC |
| FDA Product Code | | NUH, NGX, IRT | NUH, NGX, NYN, IRT |
| Power Source(s) | | Rechargeable battery | Rechargeable battery |
| Function and Design | | Electrical stimulation and heat | Electrical stimulation and heat |
| | | Heating Setting | |
| Maximum Temperature Setting | | 43°C | 43°C |
| Maximum | @ 500 Ω | 50.0 | 46.0 |
| Output Voltage | @ 2 kΩ | 90.0 | 90.4 |
| (Vp, ±20%) | @ 10 kΩ | 125 | 124 |
| Maximum | @ 500 Ω | 100 | 92.0 |
| Output Current | @ 2 kΩ | 45.0 | 45.2 |
| (mAp, ±20%) | @ 10 kΩ | 12.5 | 12.4 |
| Pulse Period (µs) | | 50 to 450 | 5.6 to 806 |
| Frequency (Hz) | | 1 to 150 | 1.24 to 178.5 |
| Maximum Phase Charge<br>(µC @ 500Ω) | | 45 | 16.9 |
| Maximum Current Density<br>(mA/cm² @ 500Ω) | | 0.667 | 3.29 |
| Maximum Power Density | | 0.0046 | 0.00165 |
| (W/cm² @ 500Ω) | | | |
| Output Patterns | ● Electrical stimulation<br>only<br>● Heat only<br>● Electrical stimulation<br>+ Heat simultaneously | ● Electrical stimulation<br>only<br>● Heat only<br>● Electrical stimulation<br>+ Heat simultaneously | |

Table 1 - Comparison to Predicate Device #1

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# Table 2 – Comparison to Predicate Device #2

| Comparison item | Subject device | Predicate device #2 | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K203574 | K190347 | |
| Device Name | HIVOX OTC Electrical<br>Stimulator | HIVOX OTC Electrical<br>Stimulator | |
| Model | EM59-1 EM59-2 | EM49-1 EM49-2 | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | |
| Intended use | EM59-1:<br>TENS: This function is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm)<br>and lower extremities<br>(leg) due to strain from<br>exercise or normal<br>household work activities.<br>SH: This function is<br>designed to be used for<br>temporary relief of minor<br>aches and pains.<br>EM59-2:<br>TENS: This function is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and | EM49-1:<br>TENS: This device is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities,<br>lower extremities,<br>abdomen and bottom due<br>to strain from exercise or<br>normal household work<br>activities.<br>EM49-2:<br>TENS: This device is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities,<br>lower extremities, | |
| | | aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm)<br>and lower extremities<br>(leg) due to strain from<br>exercise or normal<br>household work activities.<br><br>EMS: This function is<br>designed to be used for<br>stimulating healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br><br>SH: This function is<br>designed to be used for<br>temporary relief of minor<br>aches and pains. | abdomen and bottom due<br>to strain from exercise or<br>normal household work<br>activities.<br><br>EMS: This device is<br>designed to be used for<br>stimulating healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. |
| Prescription or OTC | OTC | OTC | |
| FDA product code | NUH, NGX, IRT | NUH, NGX | |
| Power Source(s) | Battery powered, d.c.<br>3.7 V, 1 × built-in<br>rechargeable lithium-ion<br>battery | Battery powered, d.c.<br>4.5 V, 3 × AAA batteries | |
| Method of Line Current<br>Isolation | N/A<br>(internal power source) | N/A<br>(internal power source) | |
| Patient<br>Leakage<br>Current | Normal<br>condition<br>(μΑ) | 6.0 | 6.0 |
| | Single fault<br>condition<br>(μΑ) | 5.6 | 5.6 |
| Number of Output Modes | | TENS: 15<br>SH: 1 | TENS: 15<br>EMS: 35<br>SH: 1 |
| | | | |
| Number of<br>output<br>Channels | Synchronous<br>or<br>Alternating? | 2 Synchronous | 2 Synchronous |
| | Method of<br>Channel<br>Isolation | By electrical circuit and<br>software | By electrical circuit and<br>software |
| Regulated Current or<br>Regulated Voltage? | | Regulated current | Regulated current |
| Software/Firmware/Micropr<br>ocessor Control? | | Yes | Yes |
| Automatic Overload Trip? | | Yes | Yes |
| Automatic No-Load Trip? |…