HIVOX OTC Electrical Stimulator, FT610-B

K211403 · Hivox Biotek, Inc. · NUH · Oct 15, 2021 · Neurology

Device Facts

• Record ID: K211403
• Device Name: HIVOX OTC Electrical Stimulator, FT610-B
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: Oct 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Device Story

Self-adhesive TENS device; provides electrical nerve stimulation and heat therapy. Inputs: user-selected intensity levels (15 settings). Operation: electrical currents delivered via 50mm x 56mm gel pads; heat function operates independently or simultaneously with TENS. Used in home/clinic settings; operated by patient (self-treatment). Output: electrical stimulation and heat to skin. Healthcare provider instructs patient on TENS regime; output provides pain relief and management of chronic pain/dysmenorrhea. Benefits: non-pharmacological pain management; temporary relief of muscle aches/cramps.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including shelf life, biocompatibility, software validation, EMC, electrical safety, and usability testing.

Technological Characteristics

Self-adhesive TENS device with integrated heat function. Materials: gel pads (50mm x 56mm). Energy: rechargeable battery. Connectivity: standalone. Software: IEC 62304 compliant. Standards: ASTM F1980-16, ISO 10993, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-6, IEC 62366-1.

Indications for Use

Indicated for symptomatic relief/management of chronic pain and temporary relief of pain in shoulder, waist, back, neck, upper/lower extremities due to exercise or household strain. Also indicated for temporary relief of dysmenorrhea (menstrual cramps) when used with OTC pain medication. Includes heat function for minor aches/pains.

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

• Electronic Pulse Stimulator (K162517)

Reference Devices

• LIVIA (K183110)

Submission Summary (Full Text)

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October 15, 2021

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

Re: K211403

Trade/Device Name: HIVOX OTC Electrical Stimulator, FT610-B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 16, 2021 Received: July 19, 2021

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 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

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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 mediation-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,

For 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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### Indications for Use

510(k) Number (if known) K211403

Device Name HIVOX OTC Electrical Stimulator (FT610-B)

#### Indications for Use (Describe)

The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve 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

| <b>2. Date of Summary</b> | October 15, 2021 |
|---------------------------|------------------------------------------------------------------------------------|
| <b>3. Submitter</b> | HIVOX BIOTEK INC. |
| <b>Address:</b> | 5F., No. 123, Xingde Rd., Sanchong Dist.,<br>New Taipei City 24158, Taiwan, R.O.C. |
| <b>Phone:</b> | [phone] |
| <b>Fax:</b> | [phone] |
| <b>Contact:</b> | Ruby Lu<br>([e-mail]) |

### 4. Identification of the Subject Device

| Proprietary Name: | HIVOX OTC Electrical Stimulator |
|-------------------------|------------------------------------------------------------|
| Model: | FT610-B |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulation Number: | 21 CFR 882.5890 |
| Device Class: | II |

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

| 510(k) Number: | K162517 |
|-------------------------|------------------------------------------------------------|
| Manufacturer: | JKH Health Co., Ltd. |
| Proprietary Name: | Electronic Pulse Stimulator |
| Model: | PL-029K13 |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH, NGX, NYN, IRT |
| Regulatory Number: | 21 CFR 882.5890 |
| Device Class: | II |

### 6. Identification of the Reference Device

| 510(k) Number: | K183110 |
|-------------------------|------------------------------------------------------------|
| Manufacturer: | LifeCare Ltd. |
| Proprietary Name: | LIVIA |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulatory Number: | 21 CFR 882.5890 |

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Device Class: II

## 7. Device Description

The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.

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

The subject device is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-thecounter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

### 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)

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- 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 (FT610-B), 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.

### 11. Substantial Equivalence Comparison

The subject device, HIVOX OTC Electrical Stimulator (FT610-B), was compared to the predicate and reference devices in the tables below:

| Comparison item | Subject device | Primary Predicate | Reference Device | Substantial<br>Equivalence<br>Determination | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K162517 | K183110 | | |
| Device Name | HIVOX OTC<br>Electrical Stimulator | Electronic Pulse<br>Stimulator | LIVIA | N/A | |
| Model | FT610-B | PL-029K13 | | | |
| Manufacturer | HIVOX BIOTEK<br>INC. | JKH Health Co., Ltd | LifeCare Ltd. | | |
| Intended use | The FT610-B is<br>designed for<br>symptomatic relief and<br>management of chronic<br>pain, and for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, neck, upper<br>extremities and lower<br>extremities due to strain<br>from exercise or normal<br>household work | TENS Mode<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>arm and leg due to<br>strain from exercise or<br>normal household and<br>work activities.<br>It is also intended for<br>symptomatic relief and<br>management of | The Livia is designed<br>for symptomatic relief<br>and management of<br>chronic pain, and 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>(arm) and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities. The Livia is | Subject device has<br>the same<br>technological<br>features as the<br>primary predicate<br>(TENS + heating)<br>excluding PMS.<br>Subject device<br>combines the heat<br>output parameter<br>on primary<br>predicate device<br>and the<br>stimulation output | |
| | indicated for temporary<br>relief of pain associated<br>with dysmenorrhea<br>(menstrual cramps)<br>when used with over-<br>the-counter pain<br>medication. In addition,<br>it also provides a heat<br>function intended for<br>temporary relief of<br>minor aches and pains. | chronic, intractable<br>pain and relief of pain<br>associated with<br>arthritis.<br><br>PMS mode<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>To be used for the<br>improvement of<br>muscle tone and<br>firmness, and for<br>strengthening muscles<br>in the arm, abdomen,<br>legs, and buttocks. Not<br>intended for use in any<br>therapy or for the<br>treatment of any<br>medical condition or<br>disease.<br>It is also intended to<br>temporarily increase<br>local blood circulation<br>in the healthy muscles<br>of lower extremities.<br><br>Heating Mode<br>Temporary relief of<br>minor aches and pains. | also indicated for<br>temporary relief of pain<br>associated with<br>dysmenorrhea<br>(menstrual cramps)<br>when used with over-<br>the-counter pain<br>medication. | parameter on<br>reference device,<br>which contain the<br>indication for use<br>on dysmenorrhea. | |
| FDA Product Code | NUH | NUH, NGX, NYN,<br>IRT | NUH | Identical to<br>reference device | |
| Prescription or OTC | OTC | OTC | OTC | Identical to<br>primary predicate<br>and reference | |
| | | | | | device |
| Power Source(s) | | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical to<br>primary predicate<br>device and<br>reference device |
| Function and Design | | Electrical stimulation<br>and heat | Electrical stimulation<br>and heat | Electrical stimulation | Identical to<br>primary predicate<br>device |
| Heating setting | | Nonadjustable | Low and high | N/A | No different in<br>safety or<br>effectiveness from<br>primary predicate<br>device |
| Maximum Temperature<br>Setting (°C) | | 43 | 43 | N/A | Identical to<br>primary predicate<br>device |
| Output Pattern of the<br>Heating | | Delivers electrical<br>stimulation and heat<br>simultaneously | Delivers electrical<br>stimulation and heat<br>simultaneously | N/A | Identical to<br>primary predicate<br>device |
| Maximum<br>Output<br>Voltage<br>(Vp-p) | @ 500 Ω | 72 ±10% | Mode 1: This mode<br>cycles the following<br>modes<br>Mode 2: 31.2 ±20%<br>Mode 3: 46.0 ±20%<br>Mode 4: 42.0 ±20%<br>Mode 5: 27.6 ±20%<br>Mode 6: 27.6 ±20%<br>Mode 7: 40.8 ±20%<br>Mode 8: 23.2 ±20% | 65.6 ±10% | No different in<br>safety or<br>effectiveness from<br>reference device |
| | @ 2 kΩ | 112 ±10% | Mode 1: This mode<br>cycles the following<br>modes<br>Mode 2: 68.0 ±20%<br>Mode 3: 90.4 ±20%<br>Mode 4: 68.8 ±20%<br>Mode 5: 60.0 ±20% | 115 ±10% | |
| | | | Mode 6: 60.0 ±20% | | |
| | | | Mode 7: 84.0 ±20% | | |
| | | | Mode 8: 50.4 ±20% | | |
| | | | Mode 1: This mode<br>cycles the following | 121 ±10% | |
| | | 120 ±10% | modes | | |
| | | | Mode 2: 118 ±20% | | |
| | | | Mode 3: 124 ±20% | | |
| | @ 10 kΩ | | Mode 4: 78.4 ±20% | | |
| | | | Mode 5: 115 ±20% | | |
| | | | Mode 6: 115 ±20% | | |
| | | | Mode 7: 124 ±20% | | |
| | | | Mode 8: 99.2 ±20% | | |
| | | | Mode 1: This mode<br>cycles the following | | |
| | | 144 ±10% | modes | 130.4 ±10% | |
| | | | Mode 2: 62.4 ±20% | | |
| | @ 500 Ω | | Mode 3: 92.0 ±20% | | |
| | | | Mode 4: 84.0 ±20% | | |
| | | | Mode 5: 55.2 ±20% | | |
| | | | Mode 6: 55.2 ±20% | | |
| | | | Mode 7: 81.6 ±20% | | |
| | | | Mode 8: 46.4 ±20% | | |
| Maximum<br>Output<br>Current<br>(mAp-p) |…