Transcutaneous Electrical Nerve Stimulator
Device Facts
| Record ID | K183288 |
|---|---|
| Device Name | Transcutaneous Electrical Nerve Stimulator |
| Applicant | Shenzhen Kentro Medical Electronics Co., Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | Jul 30, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
Device Story
Transcutaneous Electrical Nerve Stimulator (KTR-206, KTR-208, KTR-209) delivers electrical pulses to user's skin via electrode patches to provide temporary pain relief. Device consists of a host unit and electrode patches; powered by AAA batteries. User applies patches to painful areas; selects modes and intensity (0-16 levels) via on/off button and LCD interface. Dual-channel output allows coverage of multiple areas; KTR-208/209 feature independent channel intensity control. Intended for OTC use in home environments. Output parameters (waveform, frequency, pulse duration) are controlled by internal firmware. Device provides symptomatic relief by stimulating nerves, helping manage muscle pain from strain.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included verification of electrical output specifications, waveform analysis, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Biocompatibility of electrode patches was established via reference to a previously cleared device (K171381) and compliance with ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Biphasic, pulsed symmetric square wave stimulation. Powered by AAA batteries (DC 3V-4.5V). ABS plastic housing. Electrode patches (EVA foam, carbon film, hydrogel, PET) are surface-contacting (<24 hours). Dual-channel output. Microprocessor-controlled with LCD display. Compliance with IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10. Sterilization not specified (purchased as cleared components).
Indications for Use
Indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, and foot due to strain from exercise or normal household and work activities in adults.
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
- EasyStim TN28_OTC (K140168)
Reference Devices
- Health Expert Electronic Stimulator, AST-300C/AST-300D (K133929)
- Compex Wireless USA (K170903)
- Avail, Model PM601 (K172079)
Submission Summary (Full Text)
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July 30. 2019
Shenzhen Kentro Medical Electronics Co., Ltd % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, 518000 Cn
Re: K183288
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Models: KTR-206, KTR-208, KTR-209) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: June 3, 2019 Received: June 5, 2019
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. 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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K183288
#### Device Name
Transcutaneous Electrical Nerve Stimulator (KTR-206, KTR-208, KTR-209)
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|
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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
#### (1) Applicant information:
| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|----------------------|-------------------------------------------------------------|
| Address: | No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, |
| | Longgang District, Shenzhen City, Guangdong Province, China |
| Contact person: | Zewu Zhang |
| Phone number: | +86 755 3382 5998 |
| Fax number: | +86 755 3382 5996 |
| Email: | kentro@kentro.com.cn |
| Date of summary | March 1, 2019 |
| prepared: | prepared: |
### (2) Proprietary name of the device
| Trade name/model: | Transcutaneous Electrical Nerve Stimulator/ KTR-206,<br>KTR-208, KTR-209 |
|--------------------|--------------------------------------------------------------------------|
| Common name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Regulation number: | 21 CFR 882.5890 |
| Product code: | NUH |
| Review panel: | Neurology |
| Regulation class: | Class II |
#### (3) Predicate and reference devices
| <b>* Predicate device</b> | |
|---------------------------|------------------------------|
| Sponsor | Easymed Instruments Co., Ltd |
| Device Name and Model | EasyStim TN28_OTC |
| 510(k) Number | K140168 |
| Product Code | NUH |
| Regulation Number | 21 CFR 882.5890 |
| Regulation Class | II |
#### 彩 Reference device
| Sponsor | Shenzhen<br>Technology<br>Limited | OSTO<br>Company | DJO, LLC | Omron Healthcare,<br>Inc. |
|---------|-----------------------------------|--------------------------|------------------|---------------------------|
| Device | Name | Health Expert Electronic | Compex® Wireless | Avail, Model |
{4}------------------------------------------------
| and Model | | Stimulator,<br>AST-300C<br>AST-300D | Model: USA<br>and | PM601 |
|-------------------|--|-------------------------------------|-------------------|-----------------|
| 510(k) Number | | K133929 | K170903 | K172079 |
| Product Code | | NUH, NGX | NUH, NGX, NYN | NUH, NYN |
| Regulation Number | | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Regulation Class | | II | II | II |
#### (4) Description/ Design of device:
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.
The Transcutaneous Electrical Nerve Stimulator 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 painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And 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, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
| Component name | Material of Component | Body Contact Category | Contact Duration |
|-------------------|-----------------------|-----------------------|--------------------|
| Electrode patches | EVA foam, carbon | Surface skin contact | Less than 24 hours |
#### (6) Materials
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film, hydrogel, PET
We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. For details, please refer to "Biocompatibility Discussion".
#### (7) Technological characteristics and substantial equivalence:
| Item | Targeted<br>device | Predicate<br>device | Reference<br>device 1 | Reference<br>device 2 | Reference<br>device 3 | Remark |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Transcutaneo<br>us Electrical<br>Nerve<br>Stimulator | EasyStim<br>TN28_OTC | Health Expert<br>Electronic<br>Stimulator,<br>Model:<br>AST-300C<br>and<br>AST-300D | Compex®<br>Wireless USA | Avail Model /<br>PM601 | / |
| 510<br>(k)<br>number | K183288 | K140168 | K133929 | K170903 | K172079 | / |
| Regulation<br>number | 21 CFR 882.<br>5890 | 21 CFR 882.<br>5890 | 21 CFR 882.<br>5890 | 21 CFR 882.<br>5890 | 21 CFR<br>882. 5890 | Same |
| Regulation<br>description | Transcutaneo<br>us electrical<br>nerve<br>stimulator for<br>pain relief | Transcutaneo<br>us electrical<br>nerve<br>stimulator for<br>pain relief | Transcutaneo<br>us electrical<br>nerve<br>stimulator for<br>pain relief | Transcutaneou<br>s electrical<br>nerve<br>stimulator for<br>pain relief | Transcutane<br>ous<br>Electrical<br>Nerve<br>Stimulator<br>For Pain<br>Relief | Same |
| Product<br>code | NUH | NUH | NUH, NGX | NUH,<br>NGX,<br>NYN | NUH, NYN | Same |
| Class | II | II | II | II | II | Same |
| Indications<br>for use/<br>Intended use | To be used<br>for temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in<br>the shoulder,<br>back, arm,<br>leg, foot, due<br>to strain from | This device is<br>intended<br>for the relief<br>of pain<br>associated<br>with sore or<br>aching<br>muscles of<br>the lower<br>back, arms,<br>or legs due to | TENS (Mode<br>9~25)<br>To be used<br>for temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in<br>the shoulder,<br>waist, back, | The Compex<br>Wireless USA<br>TENS is used<br>for:<br>• temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles due to<br>strain from | The Avail is<br>intended for<br>the relief of<br>pain<br>associated<br>with sore or<br>aching<br>muscles of<br>the lower<br>back, arms,<br>legs, | Similar |
| | normal | exercise or | neck, arm, | normal | or feet due | |
| | household | normal | leg, and foot | household and | to strain | |
| | and work | household | due to strain | work | from | |
| | activities. | and work | from exercise | activities. | exercise or | |
| | | activities. | or normal | • the | normal | |
| | | | household | symptomatic | household | |
| | | | work | relief and | work | |
| | | | activities by | management | activities. | |
| | | | applying | of chronic, | When used | |
| | | | current to | intractable | for the | |
| | | | stimulate | pain and relief | symptomati | |
| | | | nerve. | of pain | c relief and | |
| | | | | associated | managemen | |
| | | | | with arthritis. | t of chronic, | |
| | | | | | intractable | |
| | | | | | pain and | |
| | | | | | relief of | |
| | | | | | pain | |
| | | | | | associated | |
| | | | | | with | |
| | | | | | arthritis, use | |
| | | | | | the Tap, | |
| | | | | | Shoulder, | |
| | | | | | Arm or Leg | |
| | | | | | mode of | |
| | | | | | stimulation. | |
| | | | | | Environmen | |
| | | | | | ts of Use: | |
| | | | | | Clinics, | |
| | | | | | hospital and | |
| | | | | | home | |
| | | | | | environment | |
| | | | | | S | |
| | | | | | Patient | |
| | | | | | Population: | |
| | | | | | Adult | |
| Patient | Adult | Adult | Adult | Adult | Adult | Same |
| population | | | | | | |
| Location for | OTC | OTC | OTC | OTC | OTC | Same |
| use | | | | | | |
| Basic unit specifications | | | | | | |
| Power | KTR-206:<br>2 | 2<br>Alkaline | Adaptor | Remote: | Rechargeabl | Similar |
| supply | AAA<br>batteries (DC | 1.5V<br>AA<br>(LR6) | Input:<br>100-240Vac, | Lithium<br>Polymer | e<br>Lithiumion | |
| | 3V) | Batteries | 50-60Hz, 0.1A<br>Output:5Vdc, 1A<br>Unit Input: 5Vdc,1A | (LiPo) rechargeable 3.7[V]/≥ 1500[mAh<br>Stimulation Modules:<br>Lithium Polymer (LiPo) rechargeable 3.7[V]/ ≥ 450[mAh] | battery | |
| | KTR-208: 2<br>AAA<br>batteries (DC 3V)<br>KTR-209:<br>AAA LR03<br>battery ×3<br>(DC 4.5V) | | | | | |
| Leakage<br>current | N/A (Battery<br>operated) | / | AC: 54.5μΑ,<br>DC: 0.5μA<br>(NC)/<br>AC:120.0μA,<br>DC: 0.6μΑ<br>(SFC) | N/A (Battery<br>operated) | Normal<br>Condition<br>(uA):<br><10uA<br>Single Fault<br>Condition<br>(uA):<br><50uA | Same |
| Number of<br>output<br>modes | 5 | 8 | 25 | 2 | 9 TENS<br>modes;<br>1<br>Microcurrent mode | Different<br>Note 1 |
| Number of<br>output<br>channel | 2 | 2 | 2 | 4 | 1 | Same |
| -Synchronous or<br>Alternating? | KTR-206:<br>Synchronous<br>KTR-208/<br>KTR-209:<br>Alternating | Alternating | Synchronous | Synchronous, but never 2<br>channels<br>activated at<br>the same time. | N/A | Similar |
| Software/<br>Firmware/<br>Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | Same |
| Automatic<br>Overload<br>trip | No | Yes | No | Yes | No | Same |
| Automatic<br>no-load trip | Yes | Yes | No | Yes | Yes | Same |
| Patient<br>override | On/Off button | / | Yes | Yes, push on<br>On/Off button | Yes, Power<br>On/Off | Similar |
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| control<br>method | | | | directly pause<br>the program. | button on<br>the device<br>and in the<br>App<br>software. | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indicator<br>display<br>-On/Off<br>status | Yes | Yes | Yes | Yes | Yes on App<br>and LED<br>indicator on<br>main unit. | Same |
| -Low battery | Yes | Yes | No | Yes | Yes on App | |
| -Output<br>mode | Yes | Yes | Yes | / | / | |
| -Time to<br>cut-off | Yes | Yes | Yes | / | / | |
| Automatic<br>Shut Off | Yes | Yes | Yes | No | Yes | Same |
| Timer range | 15min default<br>KTR-206:<br>5/10/15min<br>KTR-208:5/1<br>0/15/20/25/30<br>min<br>KTR-209:5/1<br>0/15/20/25/30<br>min | 20min,<br>25min,<br>30min,<br>40min<br>depending on<br>preset<br>program | 25min | / | 5-60minutes<br>and 30-180<br>minutes | Similar |
| Dimensions | KTR-206:<br>112.5*59*33.<br>3mm<br>KTR-208:<br>112.5*59*29.<br>5mm<br>KTR-209:<br>129.7*60*17.<br>8mm | 66×136×30.7<br>mm | 428mm ×<br>428.8mm ×<br>185mm | / | Device:<br>Approx. 60 ×<br>72 ×<br>15.5mm<br>(Both units<br>have same<br>dimensions)<br>Charger:<br>Approx. 158 ×<br>90 ×<br>20.5mm<br>Pad-L:<br>Approx. 219 ×<br>83.5 ×<br>9.3mm | Different<br>Note 2 |
| | | | | | | |
| | | | | | Pad-M:<br>Approx. 180<br>× 79.5<br>×<br>9.3mm | |
| Weight | KTR-206:<br>1.68oz<br>KTR-208:<br>1.79oz<br>KTR-209:<br>2.7oz | 146.5 grams | 70.5oz (2Kg)<br>(Without<br>accessories) | Remote:110<br>[g];<br>Stimulation<br>Module:2x60[<br>g];<br>Docking<br>Station 800<br>[g] | Device:<br>Approx. 42g<br>(Both units<br>have same<br>weight)<br>Pad-L:<br>Approx. 21g<br>Pad-M:<br>Approx.<br>17.5g<br>Charger:<br>Approx.<br>100g | Different<br>Note 2 |
| Housing<br>material and<br>construction | ABS | ABS | ABS | / | / | Same |
| Compliance<br>with<br>voluntary<br>standards | IEC 60601-1,<br>IEC<br>60601-1-2,<br>IEC<br>60601-2-10,<br>IEC<br>60601-1-11. | AAMI/ANSI<br>ES60601-1:2<br>005/(R)2012<br>And<br>A1:2012,<br>IEC<br>60601-1-2,<br>IEC<br>60601-2-10,<br>IEC<br>60601-1-11. | IEC60601-1;<br>IEC60601-1-<br>2;<br>IEC-60601-2-<br>10;<br>ISO10993-5;<br>ISO10993-10 | AAMI/ANSI<br>ES60601-1:20<br>05/(R)2012<br>And A1:2012,<br>IEC<br>60601-1-2,<br>IEC<br>60601-2-10,<br>IEC<br>60601-1-11. | ES 60601-1,<br>IEC<br>60601-1- 2,<br>IEC<br>60601-2-<br>10,<br>IEC<br>60601-1- 11 | Similar |
| Compliance<br>with 21CFR<br>898 | Yes | Yes | Yes | Yes | N/A | Same |
| Output specifications | | | | | | |
| Waveform | Biphasic,<br>Pulsed<br>symmetric,<br>square wave | Biphasic ,<br>Monophasic,<br>Rectangular<br>wave | Pulsed<br>symmetric,<br>biphasic,<br>rectangular<br>with<br>interphase<br>interval | Balanced,<br>asymetrical<br>Biphasic,<br>Rectangular<br>wave | Biphasic ,<br>Rectangular<br>wave | Similar |
| Maximum | KTR-206:<br>49.6V@ $500\Omega$ | 68V@500oh…
