Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

K170205 · Shenzhen Kentro Medical Electronics Co., Ltd. · NUH · May 11, 2017 · Neurology

Device Facts

• Record ID: K170205
• Device Name: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
• Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities

Device Story

Low-Frequency Therapy Instrument (models KTR-201, KTR-202, KTR-203) is a transcutaneous electrical nerve stimulator (TENS). Device consists of a host unit and hydrogel electrode patches; powered by AAA batteries. User applies electrodes to skin; selects treatment mode and intensity via device interface; LCD displays status. Device generates low-frequency electrical pulses (biphasic, symmetric, square wave) transmitted through skin to peripheral nerves to provide temporary pain relief. Used in home environment by patients. Output parameters (frequency, duration, intensity) are controlled by internal software. Device includes automatic shut-off feature. Benefits include non-invasive, temporary pain management for muscle soreness.

Clinical Evidence

Bench testing only. No clinical data. Verification included electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), software validation, and waveform output testing per FDA TENS guidance. Biocompatibility of electrode patches supported by predicate clearance (K152815).

Technological Characteristics

ABS housing; hydrogel electrodes (ISO 10993-5/10 compliant). Biphasic, symmetric, square wave output. Powered by AAA batteries. Connectivity: None. Software: Embedded firmware for mode/intensity control and automatic shut-off. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, arm, leg, and foot muscles caused by exercise or normal household/work activities. For OTC use.

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

• Health Expert Electronic Stimulator, Model AST-300C and AST-300D (K133929)
• T1040 Aurawave (K124055)
• Tyece OTC TENS Device, Model SEM44 (K150386)
• HANAROCare ReJu (K160893)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 11, 2017

Shenzhen Kentro Medical Electronics Co., Ltd Tracy Che Application Correspondent No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District Shenzhen City, 518115 CN

Re: K170205

Trade/Device Name: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 24, 2017 Received: April 26, 2017

Dear Tracy Che:

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170205

Device Name

Low-Frequency Therapy Instrument/Model: KTR-201, KTR-202, KTR-203

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, 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)

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

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# 510(k) Summary K170205

# (1) Applicant information:

| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Address: | No.3, Xihu Industry Zone, Xikeng Village, Henggang Town,<br>Longgang District, Shenzhen City, Guangdong Province, China |
| Contact person: | Zewu Zhang |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Email: | [e-mail] |
| Date of summary prepared: | May 4, 2017 |

# (2) Proprietary name of the device

| Trade name/model: | Low-Frequency Therapy Instrument /Model: KTR-201,<br>KTR-202, KTR-203 |
|--------------------|-----------------------------------------------------------------------|
| Common name: | Transcutaneous Electrical Nerve Stimulator |
| Regulation number: | 21CFR 882.5890 |
| Product code: | NUH |
| Review panel: | Neurology |
| Regulation class: | Class II |

# (3) Predicate devices

| Sponsor | Shenzhen OSTO<br>Technology<br>Company Limited | Endurance<br>Therapeutics | Tyece Ltd. | M.i.tech Co.,<br>Ltd. |
|--------------------------|------------------------------------------------------------------------------|---------------------------|------------------------------------------|-----------------------|
| Device Name<br>and Model | Health Expert<br>Electronic<br>Stimulator, Model<br>AST-300C and<br>AST-300D | T1040<br>Aurawave | Tyece OTC<br>TENS Device,<br>Model SEM44 | HANAROCare<br>ReJu |
| 510(k)<br>Number | K133929 | K124055 | K150386 | K160893 |
| Product<br>Code | NUH, NGX | NUH, NYN, NGX,<br>GZJ | NUH | NUH |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR | 21 CFR |

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| Number | | | 882.5890 | 882.5890 |
|---------------------|----|----|----------|----------|
| Regulation<br>Class | II | II | II | II |

#### (4) Description/ Design of device:

The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.

There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.

The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.

## (5) Intended use / indications:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities.

## (6) Materials

| Component name | Material of<br>Component | Body Contact<br>Category | Contact Duration |
|-------------------|--------------------------|--------------------------|--------------------|
| Electrode patches | Hydrogel | Surface skin contact | Less than 24 hours |

We have directly purchased electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K152815 and been legally marketed to US market. For details, please refer to "Biocompatibility Discussion".

## (7) Technological characteristics and substantial equivalence:

| Parameters | Subject<br>(K170205) | device | Primary predicate<br>(K133929) | Remark |
|------------|----------------------|--------|--------------------------------|--------|
| Trade name | Low-Frequency | Health | Expert | N/A |

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| | Therapy Instrument<br>(Model: KTR-201, KTR-202, KTR-203) | Electronic Stimulator,<br>Model: AST-300C and AST-300D | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | To be used for temporary relief of pain associated with sore and aching<br>muscles in the shoulder, waist, back, arm, leg<br>and foot, due to strain from exercise or<br>normal household and work activities. | To be used for temporary relief of pain associated with sore and<br>aching<br>muscles in the shoulder, waist, back, back of<br>the neck, arm, leg,<br>and foot due to strain from<br>exercise or normal household work<br>activities by applying<br>current to<br>stimulate nerve. | Similar |
| Regulation number | 21 CFR 882.5890 | 21 CFR 882.5890 | Identical |
| Product code | NUH | NUH, NGX | Similar |
| Class | II | II | Identical |
| OTC/Rx | OTC | OTC | Identical |
| Basic unit specifications | | | |
| Power supply | KTR-201: DC 3V, 30 mA<br>KTR-202: DC 4.5V, 100 mA<br>KTR-203: DC 3V, 30mA | 100-240VAC, 50-60Hz, 0.1A | Predicate is<br>powered by mains<br>supply but does not<br>affect safety and<br>effectiveness of<br>subject device |
| Output modes | KTR-201: 10<br>KTR-202:10<br>KTR-203: 5 | 25 | Identical |
| Output channels | KTR-201: 1<br>KTR-202:1<br>KTR-203: 2 | 2 | Similar. Does not<br>affect safety and<br>effectiveness of<br>subject device. |
| Software | Yes | Yes | Identical |
| Automatic Shut off | Yes | Yes | Identical |
| Timer range | 15 mins | 25 mins | Different but does<br>not affect safety<br>and effectiveness<br>of subject device. |
| Dimensions | KTR-201: 147mm x<br>59mm x 27.5mm | 428mm x 428.8mm x<br>185mm | Not applicable |
| | 100mm x 46mm<br>KTR-203: 98.9mm x<br>64mm x 31.25mm | | |
| Weight | KTR-201 (Host): 2.7oz<br>KTR-202 (Host): 5.7oz<br>KTR-203 (Host): 1.7oz | 70.5oz (2kg) (without accessories) | Not applicable |
| Housing material<br>and construction | ABS | ABS | Identical |
| Compliance with<br>voluntary<br>standards | IEC60601-1;<br>IEC60601-1-2;<br>IEC60601-1-11;<br>IEC-60601-2-10 | IEC60601-1;<br>IEC60601-1-2;<br>IEC-60601-2-10;<br>ISO10993-5;<br>ISO10993-10 | Similar |
| Compliance with<br>21 CFR 898 | Yes | Yes | Identical |
| Output specifications | | | |
| Waveform | Pulsed symmetric, biphasic, square wave | Pulse symmetric, biphasic, rectangular<br>with interphase interval | Similar |
| Maximum output<br>voltage (Vp) | 44V@500ohm<br>58V@2kohm<br>63.5V@10kohm | 44V±10% @500ohm<br>80V±10% @2kohm<br>112V±10@10kohm | Similar |
| Maximum output<br>current | 88mA@500ohm<br>29mA@2kohm<br>6.35mA@10kohm | 88mA±10% @500ohm<br>40mA±10% @2kohm<br>11.2mA±10% @ 10kohm | Similar |
| Net charge (per<br>pulse) | 0µC @500ohm | 0µC @500ohm | Identical |
| Maximum phase<br>charge | 11.7µC @500ohm | 12.78μC@500ohm | Similar |
| Maximum Average<br>Current (500ohm) | 7.4mA | 0.968mA | Although the<br>maximum average<br>current is different,<br>it is <10mA, which<br>complies with the<br>requirements of<br>IEC 60601-2-10,<br>so the difference<br>does not affect<br>safety and<br>effectiveness of the<br>subject device. |
| Maximum current<br>density | 0.15mA/cm²@500ohm | 0.235mA/cm²@500ohm | Current density is<br><2mA/cm² which<br>complies with the |
| | | | requirements of<br>IEC 60601-2-10,<br>so the difference<br>does not affect<br>safety and<br>effectiveness of the<br>subject device. |
| Maximum power<br>density | 0.56mW/cm²@500ohm | 1.38mW/cm²@500ohm | Power density is<br><0.25W/cm² and<br>does not affect<br>safety and<br>effectiveness of the<br>subject device |
| Pulse frequency | 1-200Hz | 77.3Hz | Similar |
| Pulse duration | 50-220us | 120us | Similar |
| ON time | No | 0.6s | Does not affect<br>safety and<br>effectiveness of<br>subject device |
| OFF time | No | 0.6s | Does not affect<br>safety and<br>effectiveness of<br>subject device |

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## (8) Non-clinical studies and tests performed:

Non-clinical tests have been conducted to verify that the low-frequency therapy instrument meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:

- A IEC60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC60601-1-11, 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
- A IEC60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- A IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests

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The body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K152815 and been marketed to US market. So we have reason to believe that the electrode patches are safe for the users. The electrode patches comply to the following standards.

- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- > ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

We have also conducted:

- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use

#### (9) Conclusion

Based on the above analysis and tests performed, it can be concluded that the performance and function of Low-Frequency Therapy Instrument are normal, safe and effective, and it is Substantially Equivalent (SE) to the predicate devices.