HEATING TENS/EMS, FT-810R

K223308 · Hivox Biotek, Inc. · NUH · May 13, 2023 · Neurology

Device Facts

• Record ID: K223308
• Device Name: HEATING TENS/EMS, FT-810R
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: May 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This home used device is designed to be used for adult and 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. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Device Story

Heating TENS (FT-810R) is a self-adhesive, remote-controlled TENS device for home use. It delivers electrical nerve stimulation via gel pads and provides a heat function. Device inputs include user-selected intensity levels (15 levels) and heat settings (low/high) via remote. The device operates by passing electrical currents through the skin; it features a 2.4GHz RF transceiver for wireless remote control. Output is biphasic, symmetrical electrical stimulation and heat. Healthcare providers instruct patients on TENS self-treatment regimes; patients operate the device independently. Output affects pain management by providing non-pharmacological relief. Benefits include temporary relief of muscle pain and minor aches. The device includes automatic overload/no-load trips and automatic shut-off for safety.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility, software validation, electromagnetic compatibility, electrical safety, usability, and performance verification (output waveform, impedance, and function validation).

Technological Characteristics

PC/ABS plastic housing; 3.7V Lithium-ion battery; 2.4GHz RF wireless communication. Biphasic symmetrical waveform. Regulated current output. Compliant with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5/10/23. Software validated per IEC 62304.

Indications for Use

Indicated for adults for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work. Also provides heat for temporary relief of minor aches and 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

• HIVOX OTC Electrical Stimulator (K203574)
• HIVOX OTC Electrical Stimulator (K211403)

Reference Devices

• Hi-Dow Wireless TENS/EMS (K163393)

Submission Summary (Full Text)

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May 13, 2023

Hivox Biotek Inc. Shaun Hsu Regulatory Affairs Specialist 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Taiwan

Re: K223308

Trade/Device Name: Heating Tens/ems, Ft-810r Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 14, 2023

Dear Shaun Hsu:

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

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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 (OS) 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,

# Pamela D. Scott -S

Pamela D. 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) K223308

Device Name Heating TENS (FT-810R)

#### Indications for Use (Describe)

This home used device is designed to be used for adult and 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. In addition, 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

| 2. Date of Summary | October 21, 2022 |
|--------------------|------------------------------------------------------------------------------------|
| 3. Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist.,<br>New Taipei City 24158, Taiwan, R.O.C. |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Shaun Hsu ([e-mail]) |

# 4. Identification of the Subject Device

| Proprietary Name: | Heating TENS |
|-------------------------|------------------------------------------------------------|
| Model: | FT-810R |
| 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: | K203574 |
|-------------------------|---------------------------------------------------------------------------------------|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
| Model: | EM59-1 |
| Regulatory Description: | 1) Transcutaneous electrical nerve stimulator for pain relief<br>2) Power heating pad |
| Product Code: | NUH, IRT |
| Regulatory Number: | 1) 21 CFR 882.5890<br>2) 21 CFR 890.5740 |
| Device Class: | II |

## 6. Identification of the Predicate Device #2

| 510(k) Number: | K211403 |
|-------------------------|-----------------------------------------------------------|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
| Model: | FT610-B |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relie |
| Product Code: | NUH |

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Regulatory Number: 21 CFR 882.5890 Device Class: II

#### 7. Identification of the Reference Device

| 510(k) Number: | K163393 |
|-------------------------|------------------------------------------------------------|
| Manufacturer: | Hi-Dow International, Inc. |
| Proprietary Name: | Hi-Dow Wireless TENS/EMS |
| Model: | HD-5N |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH, NGX |
| Regulatory Number: | 21 CFR 882.5890 |
| Device Class: | II |

## 8. Device Description

The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological 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 self-treatment 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 device 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.

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

This home used device is designed to be used for adult and 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. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

## 10. Non-clinical Testing

A series of safety and performance tests, as follows, were conducted on the subject

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device in accordance with FDA recognized consensus standards and/or guidance:

- Shelf life (ASTM F1980-16)
- Biocompatibility (ISO 10993-1 Edition 5.0, 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 3.2 and IEC 62366-1 Edition 1.1)
- Function Validation (Attachment 19-1 Performance Verification Report)
- Output Waveform Validation (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 8, 1999, Attachment 19-3 Output Waveform Report)
- Impedance Validation (Attachment 19-4 Impedance Test Report)

All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.

## 11. Clinical Testing

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

## 12. Substantial Equivalence Comparison

The subject device, Heating TENS (FT-810R), was compared to the predicate devices and reference device in the table below:

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#### Traditional 510(k) Section 6 – 510(k) Summary

# Table 1 – Comparison to Predicate Devices and Reference Device

| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Reference device | Substantial<br>Equivalence Determination |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K223308 | K203574 | K211403 | K163393 | |
| Device Name | Heating TENS | HIVOX OTC Electrical<br>Stimulator | HIVOX OTC Electrical<br>Stimulator | Hi-Dow Wireless<br>TENS/EMS | N/A |
| Model | FT-810R | EM59-1 | FT610-B | HD-5N | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | Hi-Dow International, Inc. | |
| Intended Use | This home used device is<br>designed to be used for adult and<br>for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, upper extremities (arm) and<br>lower extremities (leg) due to<br>strain from exercise or normal<br>household work activities. In<br>addition, it also provides a heat<br>function intended to temporarily<br>relief of minor aches and pains. | EM59-1:<br>TENS: This function is designed to be used for temporary relief of<br>pain associated with sore and aching muscles in the shoulder,<br>waist, back, upper extremities (arm) and lower extremities (leg)<br>due to strain from exercise or normal household work activities.<br>SH: This function is designed to be used for temporary relief of<br>minor aches and pains. | The FT610-B is designed<br>for 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 activities. | TENS:<br>To be used for the<br>temporary relief of pain<br>associated with sore or<br>aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm),<br>and lower extremities (leg)<br>due to strain from exercise<br>or normal household work<br>activities.<br>EMS:<br>It is intended for muscle<br>conditioning, used for<br>stimulating muscles<br>including abdomen muscles<br>in order to improve or<br>facilitate muscle<br>performance. | Subject device implements the same<br>technological features as the predicate<br>devices.<br>We are using the FT610-B to show that<br>FDA has cleared a TENS with heating<br>capability for the same indication for us<br>that we are seeking for the FT-810R that<br>has maximum charge per phase of 7.2 $\mu$<br>which is lower than the maximum<br>charge per phase of the 810R. The<br>primary predicate (predicate # 1) has a<br>maximum charger per phase of 45 $\mu$ and<br>has a heating capability and an<br>indication for use that is identical to<br>which you are seeking for the 810R.<br>Therefore, because the maximum charge<br>per phase of the 810R falls between the<br>charge per phase of the 610-B and the<br>EM59-1 and the 810R has the same<br>indication for use as the two predicates,<br>The FT-810R is substantially equivalent<br>to the legally marketed predicate.<br>Additionally, reference device used for<br>addition of wireless. |
| FDA Product Code | NUH | NUH, IRT | NUH | NUH, NGX | Identical to predicate device #2 |
| Prescription or OTC | OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | 3.7 V Lithium-ion battery | Rechargeable battery | 3.7 V Lithium-ion battery | DC 3.7V Lithium Battery | Identical |
| Function and Design | Electrical stimulation<br>and heat | Electrical stimulation<br>and heat | Electrical stimulation<br>and heat | Electrical stimulation | Identical to predicate device |
| Heating setting | Low and high | Low and high | Nonadjustable | N/A | Predicate device #2 has nonadjustable<br>heating setting which will stay<br>continuously 43℃ unless user switch off<br>the heating function. Hence, the setting<br>differences would not raise concern in |

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| | Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Reference device | Substantial<br>Equivalence Determination | |
|--------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | | | | | | safety or effectiveness from predicate<br>device | |
| | Maximum Temperature Setting<br>(°C) | 43 | 43 | 43 | N/A | Identical to predicate device | |
| | Output Pattern of the Heating | Delivers electrical<br>stimulation and heat<br>simultaneously | · Electrical stimulation only<br>· Heat only<br>· Electrical stimulation + Heat simultaneously | Delivers electrical<br>stimulation and heat<br>simultaneously | N/A | Identical to predicate device | |
| | Method of Line Current<br>Isolation | N/A<br>(internal power source) | N/A<br>(internal power source) | N/A<br>(internal power source) | Two separate devices, and<br>use independent power<br>supply system. | Identical to predicate device | |
| | Patient<br>Leakage<br>Current | Normal<br>Condition (μΑ) | < 10 | < 10 | DC: <10 AC: <100 | Identical to predicate device #2 | |
| | | Single Fault<br>Condition (μΑ) | < 50 | 5.6 | < 50 | DC: <50 AC: < 500 | Identical to predicate device #2 |
| | Number of Output Modes | 4 | TENS: 15<br>SH: 1 | 3 | 4 | Mode differences would not raise<br>concern in safety or effectiveness from<br>predicate device | |
| | Number of<br>output<br>Channels | Synchronous or<br>Alternating? | Single channel | 2 Synchronous | Single channel | 2 Channel Asynchronous | Identical to predicate device #2 |
| | | Method of<br>Channel<br>Isolation | N/A | By electrical circuit and software | N/A | Two separate devices, and<br>use independent power<br>supply system. | Identical to predicate device #2 |
| | Regulated Current or Regulated<br>Voltage? | Current | Regulated current | Regulated current | Regulated Voltage | Identical to predicate device | |
| | Software/Firmware/Microproce<br>ssor Control? | Yes | Yes | Yes | Yes | Identical | |
| | Automatic Overload Trip? | Yes | Yes | Yes | No | Identical to predicate device | |
| | Automatic No-Load Trip? | Yes | Yes | Yes | No | Identical to predicate device | |
| | Automatic Shut Off? | Yes | Yes | Yes | Yes | Identical | |
| | Patient Override Control? | Yes | Yes | Yes | Yes | Identical | |
| | On/Off Status? | Yes | Yes | Yes | Yes | Identical to predicate device #1 | |
| | Indicator<br>Display | Low Battery? | Yes | Yes | Yes | Yes | Identical to predicate device #1 |
| | | Voltage/<br>Current Level? | No | No | No | No | Identical to predicate device #1 |
| | Timer Range (minute) | 20 | 5 to 100 minutes<br>adjustable | 20 | 45 | Identical to predicate device #2 | |
| | Compliant with Voluntary<br>Standards? | ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | ES60601-1 IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | IEC 60601-1 / ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | Identical to predicate device #2 | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Reference device | Substantial<br>Equivalence Determination | | |
| | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | | | |
| | Compliant with 21 CFR 898? | Yes | Yes | Yes | Yes | Identical | |
| | Weight (g) | 102 | Approx. 125<br>(including belt clip and battery) | 47 | Remote: 62<br>Receiver: 24 | Weight differences would not raise<br>concern in safety or effectiveness from<br>predicate device | |
| | Dimensions (mm)<br>[W x H x D] | 300 × 100 × 15 | Approx. 139 × 66 × 26<br>(including belt clip) | 193 × 95 × 15 | Remote: 108 × 53 × 15<br>Receiver: Φ57 × 12 | Dimension differences would not raise<br>concern in safety or effectiveness from<br>predicate device | |
| | Housing Materials and<br>Construction | PC/ABS plastic | Plastic (ABS) enclosure | PC/ABS plastic | ABS | Identical to predicate device | |
| | Waveform | Biphasic, Symmetrical | Biphasic | Biphasic, Symmetrical | Pulsed Biphasic | Identical to predicate device | |
| | Shape | Rectangular | Rectangular | Rectangular | Rectangular | Identical | |
| Maximum<br>Output<br>Voltage<br>(Vp-p, ±10%) | @ 500 Ω | 72 | 100 | 72 | (TENS) MODE 3:<br>48.5V@500Ω<br>(TENS) MODE 4:<br>41.1V@500Ω<br>(EMS) MODE 1:<br>37.9V@500Ω<br>(EMS) MODE 2:<br>46.8V@500Ω | No significant differences would raise<br>concern in safety or effectiveness from<br>predicate device | |
| | @ 2 kΩ | 112 | 180 | 112 | 41.1V@500Ω<br>(EMS) MODE 1:<br>37.9V@500Ω | | |
| | @ 10 kΩ | 120 | 250 | 120 | 37.9V@500Ω<br>(EMS) MODE 2:<br>46.8V@500Ω | | |
| Maximum<br>Output<br>Current<br>(mAp-p,<br>±10%) | @ 500 Ω | 144 | 200 | 144 | (TENS) MODE 3:<br>97mA@500Ω<br>(TENS) MODE 4:<br>82.2mA@500Ω<br>(EMS) MODE 1:<br>75.8mA@500Ω<br>(EMS) MODE 2:<br>93.6mA@500Ω | No significant differences would raise<br>concern in safety or effectiveness from<br>predicate device | |
| | @ 2 kΩ | 56 | 90 | 56 | (TENS) MODE 4:<br>82.2mA@500Ω<br>(EMS) MODE 1:<br>75.8mA@500Ω | | |
| | @ 10 kΩ | 12 | 25 | 12 | (EMS) MODE 1:<br>75.8mA@500Ω<br>(EMS) MODE 2:<br>93.6mA@500Ω | | |
| | Pulse Width (µs) | 200 - 400 | 50 to 450 | 100 | (TENS) MODE 3:<br>Continuous<br>(TENS) MODE 4: 92.5<br>(EMS) MODE 1: 4.6<br>(EMS) MODE 2: 4.8 | No significant differences would raise<br>concern in safety or effectiveness from<br>predicate device<br>NOTE: Referring to "Maximum Phase<br>Charge" for details | |
| | Frequency (Hz) | 6~45 | 1 to 150 | 100 | (TENS) MODE 3: 1.28<br>(TENS) MODE 4: 1~59.8<br>(EMS) MODE 1: 52.3<br>(EMS) MODE 2: 5.8 | No significant differences would raise<br>concern in…