Tyece OTC TENS Model

K200838 · Tyece Limited · NUH · Aug 12, 2020 · Neurology

Device Facts

• Record ID: K200838
• Device Name: Tyece OTC TENS Model
• Applicant: Tyece Limited
• Product Code: NUH · Neurology
• Decision Date: Aug 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

Device Story

Portable, battery-operated (4.5V) single-channel TENS device; delivers electrical stimulation via electrodes to muscles for temporary pain relief. User selects from 4 programs; intensity adjustable (0-110mA) via constant voltage. LCD displays operation status, mode, intensity, timer, and battery level. Used by healthy adults in home environment. Device includes automatic shut-off, overload, and no-load trip safety features. Output waveform is symmetrical biphasic rectangular. Healthcare provider/patient uses device to manage muscle pain; output affects nerve/muscle stimulation to provide relief.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment safety (IEC 60601-1-11), and nerve/muscle stimulator performance (IEC 60601-2-10).

Technological Characteristics

Portable TENS device; ABS housing; 4.5V (3x AAA) battery power; single-channel; symmetrical biphasic rectangular waveform; constant voltage output; 4 programs; LCD interface; 1.2m electrode cables. Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, and 21 CFR 898.

Indications for Use

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

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

• LT3060 (K130802)

Reference Devices

• Savia OTC TENS Model EM-38 (K113321)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

August 12, 2020

Tyece Limited % Maria Griffin Senior Consultant mdi Consultants, Inc. 55 Northern Blvd, Ste 200 Great Neck. New York 11021

Re: K200838

Trade/Device Name: Tyece OTC TENS Device EM26, EM27, EM28, and EM29 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: May 27, 2020 Received: June 1, 2020

Dear Maria Griffin:

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.

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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 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 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.

Vivek Pinto, PhD 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) K200838

Device Name

Tyece TENS Device Models: EM26, EM27, EM28, EM29

Indications for Use (Describe)

The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for TYECE, a company focused on beauty, health, and fitness. The word "TYECE" is written in large, bold, maroon letters. Below the company name, the words "Beauty . Health . Fitness" are written in a smaller, lighter font.

Unit 803, Block A. Po Lung Centre 11 Wang Chiu Road, Kowloon Bay, Hong Kong Tel: [phone] . Fax [phone] www.tvece.com

## 510k Summary

The assigned 510(k) number is: _K200838_

- 1. Submitter's identifications:
Tyece Limited Unit 803, Block A, Po Lung Centre, 11 wang Chiu Road, Kowloon Bay, Hong Kong Contact: Parshid Falahati Telephone: [phone] Email: [e-mail]

Date of Summary Preparation: July 28, 2020

- 2. Device:
Trade Name: Tyece OTC TENS Device EM26, EM27, EM28 and EM29

Common Name: TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product code: NUH Regulation class: II Regulation Number: 21 CFR 882.5890

- 3. Predicate Device
Trade/Device Name: LT3060 510(k) Number: K130802

- 4. Reference Device
Trade/Device Name: Savia OTC TENS Model EM-38 510(k) Number: K113321

### 5. Device Description:

The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of

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pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features:

- a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device.
- b. It contains 4 programs, similar to the predicate device which has 12 programs
- The output strength is adjustable from 0-110mA, similar to the predicate device at 0-C. 96mA, via regulated voltage.
- d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.

#### 6. Intended Use:

The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

#### 7. Technological Comparison to Predicate Devices:

Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has similar technological characteristics to the predicate device in product design, material, energy source type, main program modes and the main output waveform etc. Through detailed calculation comparison

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of stimulation output energy, we found that the output levels for the subject device and the predicate device are very similar and within acceptable ranges as specified in the FDA guidance. We believe that the differences between the two devices do not affect the determination of substantial equivalence.

### 8. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards. The device passes all testing performed below:

- -IEC 60601-1: 2005 + AM1 (2012) Medical Devices Part 1: General Requirement for Safety Report
- -IEC 60601-1-2:2014 Medical Devices Part 2: General Requirements for Safety – Harmonized Standards: Electromagnetic Compatibility -Test and Requirement Report
- -IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Report
- -IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Report
- -Software Validation

The Tyece OTC TENS Device, Models EM26, EM27, EM28 and EM29, by applying the same stimulus parameters has the same intended use as the cleared predicate device, LT3060 (K130802).

A summary of the technological characteristics of Models EM26, EM27, EM28 and EM29 compared to the predicate device is given below:

## Basic Unit Characteristics:

| Item | Subject Device | Predicate Device | Discussion of differences |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Number | K200838 | K130802 | Similar |
| Device Name, Model | Tyece OTC TENS<br>Device EM26, EM27,<br>EM28 and EM29 | LT3060 | Similar |
| Manufacturer | Savia<br>Electronics<br>(Shenzhen) Co.<br>Ltd. | Shenzhen<br>Dongdixin<br>Technology<br>Co., Ltd | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | | | |
| Intended Use | The Tyece OTC TENS<br>Device EM26 is<br>intended for use by<br>healthy adults for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder and neck<br>due to strain from<br>exercise or normal<br>household and work<br>activities.<br>The Tyece OTC TENS<br>Device EM27 is<br>intended for use by<br>healthy adults for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the lower<br>extremities (leg) due<br>to strain from exercise<br>or normal household<br>and work activities.<br>The Tyece OTC TENS<br>Device EM28 is<br>intended for use by<br>healthy adults for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the upper<br>extremities (arm) due<br>to strain from exercise<br>or normal household<br>and work activities.<br>The Tyece OTC TENS<br>Device EM29 is<br>intended for use by<br>healthy adults for | LT3060 OTC TENS<br>Device:<br>The device is<br>designed to be used<br>for temporary relief<br>of pain associated<br>with sore and<br>aching muscles in<br>the shoulder, waist,<br>back, neck, upper<br>extremities (arm),<br>and lower<br>extremities (leg) due<br>to strain from<br>exercise or normal<br>household work<br>activities. | Same |
| Prescription or OTC | OTC | OTC | Same |
| Power Source | 4.5V (3 x 1.5V AAA,<br>type<br>LR03 Alkaline<br>batteries) | Battery<br>powered, d.c.<br>9.0V, one 6F22<br>battery | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| -Method of Line Current Isolation | No line connection<br>possible when<br>connected to body | No line connection<br>possible when<br>connected to body | Same |
| -Patient Leakage Current<br>- Normal condition<br>- Single fault condition | Not applicable, no<br>line connection, no<br>AC charger<br>connection or<br>operation.<br>Connection method<br>does<br>not allow AC<br>charger<br>connection to<br>patient | 0.61uA<br>0.68uA | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| Average DC current through<br>electrodes when device is on<br>but no pulses are being applied | 0μΑ | 0μΑ | Same |
| Number of Output Models | TENS | TENS | Same |
| Number of Output Channels | 1 | 2 | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| -Synchronous or Alternating? | Synchronous | Alternating | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| -Method of Channel Isolation | Single Channel | Dual Channel | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| Regulated Current or Regulated | Constant Voltage | Constant Voltage | Same |
| Software/Firmware/Micropr<br>ocessor Control? | YES | YES | Same |
| Automatic Overload Trip? | YES | YES | Same |
| Automatic No-Load Trip? | YES | YES | Same |
| Automatic Shut Off? | YES | YES | Same |
| Patient Override Control? | YES | YES | Same |
| Indicator Display:<br>On/Off Status?<br>-<br>Low Battery?<br>-<br>Voltage/Current Level?<br>- | YES<br>YES<br>YES (Voltage) | YES<br>YES<br>YES (Voltage) | Same |
| Timer Range (minutes) | 30 mins - Program A,<br>25 mins - Programs B,<br>C, D | 1 - 60 mins | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| Compliance with Voluntary Standards? | 60601-1 & 60601-1-2 | 60601-1 & 60601-1-<br>2 | Same |
| Compliance with 21 CFR 898? | YES | YES | Same |
| Weight (lbs., oz.) | EM26 - Approx.<br>0.6 lb (280g) with<br>batteries EM27 -<br>Approx. 0.34 lb<br>(155g) with<br>batteries EM28 -<br>Approx. 0.39 lb<br>(175g) with<br>batteries<br>EM29 - Approx.<br>0.46 lb (210g)<br>with batteries | Approx. 0.28<br>lb with<br>batteries | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Dimensions (in.) [W x H x D] | 3.4 x 1.4 x 2.3 in | 4.5 x 2.55 x 0.9 in | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device |
| Housing Materials and Construction | ABS | ABS | Same |
| Electrode Cable Length | 1.2m | 1.2m | Same |

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# Output Specifications

| Attribute | | Subject Device:<br>Tyece OTC TENS<br>Device, Models<br>EM26, EM27, EM28<br>and EM29 | Predicate Device:<br>LT3060 (K130802) | Discussion of Difference |
|---------------------------------------------|-------|-------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------|
| Waveform | | Symmetrical<br>biphasic | Symmetrical<br>biphasic | Same |
| Shape | | Rectangular | Rectangular | Same |
| Channels | | Single | Dual | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| Maximum Output Voltage<br>(Volts)<br>(±20%) | @500Ω | 54.4Vp-p | 48Vp-p | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| | @2kΩ | 112Vp-p | 114Vp-p | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| | @10Ω | 198Vp-p | 115Vp-p | |
| Maximum Output Current<br>(mA)<br>(±20%) | @500Ω | 108.8mAp-p | 96mAp-p | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| | @2kΩ | 56mAp-p | 57mAp-p | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| | @10Ω | 19.8mAp-p | 11.5mAp-p | |
| Amplitude (mA) | | 0-110 | 0-96 | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| Frequency (Hz) | | 4-110 | 1-150 | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| Pulse Width (μS) | | 60-220µs per phase | 50-300µs per phase | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |

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| For multiphasic<br>waveforms only | Symmetrical phases? | | No multiphasic waveforms | Yes | Different but does not<br>adversely impact safety and<br>effectiveness of subject<br>device. |
|---------------------------------------------------------------------------------------|---------------------|--|--------------------------|----------------|----------------------------------------------------------------------------------------------|
| | Phase Duration | | | 50-300uS | |
| Power ON indicator | | | LCD | LCD | Same |
| Net Charge (μC per pulse) (if zero<br>state method of achieving zero net<br>charge) | | | 0.00246 μC@500Ω | 0 μC@500Ω | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| Maximum Phase Charge (μC)<br>@500Ω | | | 0.02398 | 0.0288 | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| Maximum Current Density (mA/cm²)<br>@500Ω | | | 0.52 | 1.15 | |
| Maximum Power Density<br>(W/ cm²) @500Ω (using smallest<br>electrode conductive area) | | | 0.033 | 0.373 | |
| RMS Voltage (RMSV)<br>(±20%) | @500Ω | | 5.5V | 5.2V | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| | @2kΩ | | 16.3V | 14.2V | |
| | @10Ω | | 27.2V | 20.2V | |
| RMS Current (RMSA)<br>(±20%) | @500Ω | | 11mA | 10mA | |
| | @2kΩ | | 7.35mA | 8.85mA | |
| | @10Ω | | 2.02mA | 1.88mA | |
| Burst Mode | | | | | Different but does not<br>adversely impact safety<br>and effectiveness of<br>subject device |
| - Pulses per burst | | | 110 | N/A | |
| - Burst per second | | | 2 | | |
| - Burst duration (seconds) | | | 0.5s | | |
| - Duty cycle: Line (b) x Line (c) | | | 1 | | |
| ON Time (seconds) | | | N/A | N/A | Same |
| OFF Time (seconds) | | | N/A | N/A | |
| Additional Features (specify, if<br>applicable) | | | Not applicable | Not applicable | Same |

### Summary for the technology comparison

The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has similar technological characteristics to the predicate device in product design, material, energy source type, main program modes and the main output waveform etc. Through detailed calculation comparison of stimulation output energy, we found that the output levels for the subject device and the predicate device are very similar and within acceptable ranges as specified in the FDA guidance. We believe that the differences between the two devices do not affect the determination of substantial equivalence.

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#### Conclusion

The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 has the same intended use and similar technological characteristics as the cleared predicate device. Moreover, verification and validation tests demonstrate that the differences in the submitted models maintain the same safety and effectiveness as that of the cleared device. Therefore, we conclude that the subject device is substantially equivalent to the predicate device.