Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · GZJ · Jan 24, 2023 · Neurology

Device Facts

• Record ID: K222879
• Device Name: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jan 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.

Device Story

TENS WMPS6-1 is an electrical nerve stimulator for pain relief; applies electrical current to skin via electrodes. Device features 18 programs (13 standard, 5 editable); powered by 6 1.5V batteries or AC 100-240V. Six outlet sockets connect to electrodes via lead wires. Operated by clinician or patient (prescription use); used in clinical or home settings. Device transforms electrical input into biphase rectangular pulse outputs to stimulate nerves. Healthcare providers use device to manage chronic, post-surgical, or post-traumatic pain. Benefits include non-pharmacological pain management. Device includes microprocessor control for stimulation parameters.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing only, including electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance requirements for nerve/muscle stimulators (IEC 60601-2-10).

Technological Characteristics

ABS housing; microprocessor-controlled; 6 output channels; biphase rectangular pulse waveform; 1-100Hz frequency; 50-250μs pulse width; 50V/100mA max output @500Ω. Powered by 6x1.5V batteries or AC adapter. Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10.

Indications for Use

Indicated for patients requiring pain relief, specifically for symptomatic relief of chronic intractable pain and as adjunctive treatment for post-surgical and post-traumatic pain.

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

• Transcutaneous Electrical Nerve Stimulator (K220578)

Submission Summary (Full Text)

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January 24, 2023

Wuxi Jiajian Medical Instrument Co., Ltd Wu Zhifang General manager No.35 Baiqiao Rd., Ehu Town, Xishan District, WuXi, JiangSu 214116 China

Re: K222879

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: December 7, 2022 Received: December 8, 2022

Dear Wu Zhifang:

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 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.

Lauren E. Woodard -S

for Amber Ballard, PhD 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) K222879

Device Name

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

Indications for Use (Describe)

The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.

| 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) |

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# 510(k) Summary [As required by 21 CFR 807.92]

| 1. Submission Information | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K222879 |
| Date: | January 23, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd. |
| | No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China<br>214116 |
| | Contact:Wu Zhifang |
| | E-mail: [e-mail] |
| | Tel: [phone] |
| 2. Device Description | |
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6- 1) |
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | The Transcutaneous Electrical Nerve Stimulator (model: TENS<br>WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief<br>by applying an electrical current to electrodes on a patient's skin to treat<br>pain. In particular, the TENS WMPS6-1 is indicated for use for<br>symptomatic relief of chronic intractable pain and adjunctive treatment in<br>the management of post-surgical and post traumatic pain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is<br>an electrical nerve stimulator indicated for use for pain relief by applying<br>an electrical current to electrodes on a patient's skin to treat pain.<br>The device has 18 programs (13 standard programs and 5 editable<br>programs), powered by 6 pieces of 1.5V batteries or AC 100-240V,<br>comprising electronic stimulatory module and accessories of lead wires,<br>electrodes.<br>Six outlet sockets are used to connect skin electrodes by lead wires. The<br>accessories of electrodes is 510(k) cleared device (K192568), Size:<br>50*50mm. |

## 3. Predicate Device Identification

| Predicate 510(k) Number: | K220578 |
|---------------------------|--------------------------------------------|
| Marketing clearance date: | May 25, 2021 |
| Product name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |

# 4. Substantially Equivalent Comparison Conclusion

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| Parameters | New Device | Predicate Device | Comparison | |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------|
| 510(k) Number | K222879 | K220578 | -- | |
| Device Name | Transcutaneous Electrical<br>Nerve Stimulator (model: TENS<br>WMPS6-1) | Transcutaneous Electrical<br>Nerve Stimulator (RJTENS-1) | -- | |
| Manufacturer | Wuxi Jiajian Medical<br>Instrument Co., Ltd | Bozhou Rongjian Medical<br>Appliance Co.,Ltd. | -- | |
| Intended use | Transcutaneous Electrical<br>Nerve Stimulator(model: TENS<br>WMPS6-1) is an electrical<br>nerve stimulator indicated for<br>use for pain relief by applying<br>an electrical current to<br>electrodes on a patient's skin to<br>treat pain. In particular, this<br>device is indicated for use for<br>symptomatic relief of chronic<br>intractable pain and adjunctive<br>treatment in the management of<br>post surgical and post traumatic<br>pain. | Transcutaneous Electrical<br>Nerve Stimulator is an electrical<br>nerve stimulator indicated for<br>use for pain relief by applying<br>an electrical current to<br>electrodes on a patient's skin to<br>treat pain. In particular, this<br>device is indicated for use for<br>symptomatic relief of chronic<br>intractable pain and adjunctive<br>treatment in the management of<br>post surgical and post traumatic<br>pain. | Same | |
| Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC9V(6×1.5V disposable<br>alkaline battery R14/UM2 type)<br>Power adapter:<br>Model:GTM96060-0612-3.0<br>Input:100-240V~,50/60Hz;<br>Output:DC9V,0.5A | 1.5Vx4 AAA alkaline battery | Similar<br>Note 1 | |
| - Method of Line<br>Current Isolation | N/A | N/A | Same | |
| - Patient Leakage<br>Current | -- | -- | -- | |
| - Normal<br>Condition (μΑ)<br>- Single Fault<br>Condition (μA) | 2μA<br>NA | 2μA<br>NA | Same | |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (μΑ) | <0.01μA | <0.01μA | Same | |
| Number of program | 18 | 16 | Similar<br>Note 2 | |
| Number of Output<br>channels: | 6 (No more than two channels<br>can be used on the same | 2 | Similar<br>Note 2 | |
| | - Synchronous<br>or Alternating? | person.) | Synchronous | Same |
| | - Method of<br>Channel Isolation | By Transformer | By Transformer | Same |
| | Regulated Current or<br>Regulated Voltage? | Current control | Current control | Same |
| | Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Same |
| | Automatic Overload<br>Trip? | No | No | Same |
| | Automatic No-Load<br>Trip? | No | No | Same |
| | Automatic Shut Off? | Yes | Yes | Same |
| | User Override<br>Control? | Yes | Yes | Same |
| | On/Off<br>Status? | Yes | Yes | Same |
| | Indicat<br>or Low<br>Battery? | Yes | Yes | Same |
| | Display Voltage/Cu<br>rrent<br>Level? | Yes | Yes | Same |
| | Timer Range<br>(minutes) | 1~99 min | 10~90 min | Similar<br>Note 2 |
| | Compliance with<br>Voluntary Standards? | ANSI AAMI ES60601-1, IEC<br>60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC<br>60601-1-2, IEC 60601-2-10 | Same |
| | Compliance with 21<br>CFR 898? | Yes | Yes | Same |
| | Weight (grams) | Approx.650g without battery | Approx.96g without battery | Similar<br>Note 3 |
| | Dimensions (mm) [W<br>x H x D] | 238*175*72mm | 140*64*28 mm | Similar<br>Note 3 |
| | Housing Materials &<br>Construction | ABS | ABS | Same |
| | Waveform | Biphase | Monophasic | Similar<br>Note 4 |
| | Shape | Rectangular pulse | Rectangular pulse | Same |
| | Maximum Output<br>Voltage (volts) | 50V±20% @500Ω | 30V±10% @500Ω | |
| | Maximum Output<br>Current (specify<br>units) | 100mA±20% @500Ω | 60mA±10% @500Ω | Similar<br>Note 5 |
| | Pulse width (usec) | 50-250μs±20% | 75-300μs±10% | |
| Pulse Period (msec) | 10-1000ms | 8.33-1000ms | | |
| Max. pulse frequency<br>(Hz) [or Rate (pps)] | 1-100Hz±10% | 1-120Hz±10% | | |
| Net Charge ( $\mu$ C per<br>pulse) | 0 $\mu$ C @500Ω(Method: Balanced<br>waveform) | 0.65 $\mu$ C @500Ω | | |
| Maximum Phase<br>Charge, ( $\mu$ C) | 25 $\mu$ C @500Ω | 18 $\mu$ C @500Ω | | |
| Maximum Average<br>Current, (mA) | 2.5mA @500Ω | 2.16mA @500Ω | Similar<br>Note 6 | |
| Maximum Current<br>Density, (mA/cm², r.m.s.) | 0.1mA/cm² @500Ω | 0.09mA/cm² @500Ω | | |
| Maximum Average<br>Power Density, (mW/cm²) | 5mW/cm² @500Ω | 2.59mW/cm² @500Ω | | |
| Accessories | Electrodes, cables,battery(users<br>need to purchase their<br>own),adapter(users need to<br>purchase their own) | Electrodes, cables, battery | Similar<br>Note 3 | |

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## Comparison in details:

## Note 1:

The power source(s) and battery charge of the proposed device are a little different from the predicate device, but these differences are insignificant in terms of safety or effectiveness. In addition, the proposed device has passed the electrical safety test and ,so these differences don't raise any new safety and effectiveness issues.

## Note 2:

The number of modes and treatment times are only different by design; the core principles of these two devices are similar, although the number of channels is increased to 6 channels, the same person can use up to two channels, which is the same as the number of predicate device channels, and does not cause security and effectiveness problems.

## Note 3:

The weight, dimensions and accessories of the proposed device are a little different from the predicate device, this is a slightly different product design, but these differences are insignificant in terms of safety or effectiveness.

#### Note 4:

The output waveform of the new device is different from that of the predicate device. In addition, the proposed device has passed AAMI / ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10 tests, so these differences don't raise any new safety and effectiveness issues.

## Note 5:

There are some differences on the maximum output voltage and maximum output current between the proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and these parameters have passed IEC 60601-2-10 test codes. So these differences will not raise any new safety and effectiveness issues. Although the pulse period and frequency of the proposed device are a little different from the predicate device, but they are all

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compliance with IEC 60601-2-10 requirements. So, the minor differences of function specification will not raise any safety or effectiveness issue.

## Note 6:

The net charge and maximum phase charge of the proposed device are different from the predicate device, and both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.The maximum average current, maximum current density, maximum average power density have some differences between proposed device and predicate device. Both of them meet maximum average current <10mA, maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore, these differences won't raise any new safety and effectiveness issues.Also, all programs have passed AAMI/ANSI ES 60601-2-10 tests. Therefore, these differences don't raise any new safety and effectiveness issues.

#### 5. Non-Clinical Test Conclusion

Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:

• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD);

· IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;

· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests:

## 6. Clinical Test

Clinical data was not including in this submission.

#### 7. Conclusions

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the subject device is substantially equivalent to the predicate device.