Transcutaneous Electrical Nerve Stimulator

K202893 · Wuxi Jiajian Medical Instrument Co., Ltd. · GZJ · Jun 18, 2021 · Neurology

Device Facts

• Record ID: K202893
• Device Name: Transcutaneous Electrical Nerve Stimulator
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jun 18, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Transcutaneous Electrical Nerve Stimulator 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, this device 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

Battery-powered portable TENS device; delivers gentle electrical current to nerves and muscle groups via skin-applied electrodes. Device features electronic stimulatory module, lead wires, and electrodes. User interface includes two output sockets, adjustable treatment programs, and timer. Operated by patient or clinician to manage pain; output intensity and duration are user-adjustable. Device provides symptomatic relief for chronic intractable, post-surgical, and post-traumatic pain. Safety features include automatic overload trip and user override control.

Clinical Evidence

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

Technological Characteristics

Battery-powered (4x AAA alkaline) TENS device; ABS housing; 2 output channels; monophasic rectangular pulse waveform. Frequency 1-120Hz; pulse width 75-300μs. Connectivity via lead wires to 50x50mm electrodes. Complies with IEC 60601-1, 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 adjunctive treatment of 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

• Jiajian® TENS (K112288)

Reference Devices

• K192568 (electrodes)

Submission Summary (Full Text)

{0}------------------------------------------------

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 18, 2021

Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Regulatory Assurance No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China

Re: K202893

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: April 25, 2021 Received: May 17, 2021

Dear Caihong Sun:

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

{1}------------------------------------------------

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,

For

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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202893

Device Name

Transcutaneous Electrical Nerve Stimulator

Indications for Use (Describe)

The Transcutaneous Electrical Nerve Stimulator 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, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

Type of Use (Select one or both, as applicable)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Jiajian. The logo is in a teal color and features the text "JIA JIAN" in a sans-serif font. A check mark is used in place of the space between the two words. Below the text is the company name in Chinese characters.

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

# 1. Submission Information:

| 510(k) Number: | K202893 |
|----------------------------|----------------------------------------------------------------------------|
| Date: | April 15, 2021 |
| Type of 510(k) Submission: | Special |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| | No.35 Baiqiao Rd., Ehu Town, Xishan District, |
| | Wuxi, Jiangsu, China 214116 |
| | E-mail: [e-mail] |
| | Tel: [phone] |
| Contactor: | Doris Dong |
| | [Consultant, from Shanghai CV Technology Co., Ltd.] |
| | Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China |
| | E-mail: [e-mail] |
| | Tel: [phone] / Fax: [phone] |

# 2. Device Description:

| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator is an electrical nerve<br>stimulator indicated for use for pain relief by applying an electrical current<br>to electrodes on a patient's skin to treat pain. In particular, this device is<br>indicated for use for symptomatic relief of chronic intractable pain and<br>adjunctive treatment in the management of post surgical and post traumatic<br>pain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical<br>Nerve Stimulator for pain relief. The stimulator sends gentle electrical<br>current to underlying nerves and muscle group via electrodes applied on<br>the skin.<br>The device has standard programs and edit programs. It is a<br>battery-powered portable device, comprising electronic stimulatory<br>module and accessories of lead wires, electrodes and battery.<br>Two 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. |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo for a company called JIA JIAN. The logo is in blue and features the company name in a stylized font. There is a check mark above the letters IA. Below the company name are Chinese characters.

### 3. Substantially Equivalent Comparison Conclusion

| Parameters | Modified Device | Predicate Device | Remark | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------|
| 510(k) Number | K202893 | K112288 | -- | |
| Device Name | Transcutaneous Electrical Nerve<br>Stimulator | Jiajian® TENS | -- | |
| Model | TENStem eco basic | / | -- | |
| Manufacturer | Wuxi Jiajian Medical Instrument<br>Co., Ltd | Wuxi Jiajian Medical<br>Instrument Co., Ltd | Same | |
| Intended use | Transcutaneous Electrical Nerve<br>Stimulator is an electrical nerve<br>stimulator indicated for use for pain<br>relief by applying an electrical<br>current to electrodes on a patient's<br>skin to 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. | Jiajian® TENS 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) | 1.5Vx4 AAA alkaline battery | 9V Battery type 6F22 | Similar<br>Note 1 | |
| - Method of Line<br>Current Isolation | N/A | NA | Same | |
| - Patient Leakage<br>Current | -- | -- | | |
| - Normal<br>Condition (μΑ) | 2μΑ | 2μΑ | Same | |
| - Single Fault<br>Condition (μΑ) | NA | NA | | |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (μΑ) | <0.01μΑ | <0.01μΑ | Same | |
| Number of program | 16 | 12 | Similar<br>Note 1 | |
| Number of Output<br>channels: | 2 | 2 | Same | |
| - Synchronous or<br>Alternating? | Synchronous | Synchronous | Same | |
| | Method of Channel Isolation | | | |
| | Regulated Current or Regulated Voltage? | By Transformer | By Transformer | Same |
| | Software/Firmware/Microprocessor Control? | Current control | Voltage control | Similar Note 2 |
| | Automatic Overload Trip? | Yes | Yes | Same |
| | Automatic No-Load Trip? | No | No | Same |
| | Automatic Shut Off? | No | No | Same |
| | User Override Control? | Yes | Yes | Same |
| | | Yes | Yes | Same |
| Indicat or Display | On/Off Status? | Yes | Yes | Same |
| | Low Battery? | Yes | Yes | Same |
| | Voltage/Current Level? | Yes | Yes | Same |
| | Timer Range (minutes) | 10~90 min | 1~99 min | Similar Note 2 |
| | Compliance with Voluntary Standards? | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Same |
| | Compliance with 21 CFR 898? | Yes | Yes | Same |
| | Weight (grams) | Approx.96g without battery | 170g without battery | Similar Note 1 |
| | Dimensions (mm) [W x H x D] | 140*64*28 mm | 114 x 59 x 27 mm | Similar Note 1 |
| | Housing Materials & Construction | ABS | ABS | Same |
| | Waveform | Monophasic | Monophasic | Same |
| | Shape | Rectangular pulse | Rectangular | Same |
| | Maximum Output Voltage (volts) | $30V±20% @500Ω$ | $35V @500Ω$ | |
| | Maximum Output Current (specify units) | $60mA±20% @500Ω$ | $70mA @500Ω$ | Similar |
| | Pulse width (usec) | $75-300μs±20%$ | $60-300μs±20%$ | Note 3 |
| | Pulse Period (msec) | 8.33-1000ms | 8.33-2000ms | |
| | Max. pulse frequency (Hz) [or Rate (pps)] | 1-120Hz±20% | 0.5-120Hz±20% | |
| | Net Charge (µC per pulse) | $0.65μC @500Ω$ | $0.83μC @500Ω$ | Similar Note 4 |
| Maximum<br>Charge, (µC) | Phase | 18µC @500Ω | 23.04µC @500Ω | |
| Maximum Average<br>Current, (mA) | | 2.16mA @500Ω | 2.76mA @500Ω | |
| Maximum Current<br>Density, (mA/cm²,<br>r.m.s.) | | 0.09mA/cm² @500Ω | 0.35mA/cm² @500Ω | |
| Maximum Average<br>Power Density,<br>(mW/cm²) | | 2.59mW/cm² @500Ω | 13.27mW/cm² @500Ω | |
| Accessories | | Electrodes, cables, battery | Electrodes, cables, battery | Same |

# Table 1 - TENStem eco basic Parameters

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for JIA JIAN, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" with a check mark above the "I", and the Chinese name is "佳健医疗" below the English name. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for JIA JIAN, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" with a check mark above the "I" and the registered trademark symbol next to the "N". Below the English name is the Chinese name for the company, which translates to "Jia Jian Medical".

Comparison in details:

# Note 1:

The proposed device has more treatment programs than the predicate device K112288, but all of the treatment programs have passed the IEC 60601-2-10 and IEC 60601-1 test codes. So, this difference will not raise any safety or effectiveness issue.

The weight, dimensions of the proposed device are a little different from the predicate device K112288, but these differences are insignificant in the terms of safety or effectiveness. Besides, the battery used is different from the predicate device, but the battery used by the proposed device is commonly used in the market. Therefore, this difference will not raise any safety or effectiveness issue.

# Note 2:

The "Regulated Current or Regulated Voltage" between the proposed device and the predicate device has slight difference. But both of them have passed IEC 60601-1 test code, so this difference won't raise any new safety and effectiveness issues.

There is a little difference on treatment time range between proposed device and predicate device. But the treatment time can be adjusted by user as they want. So, the difference of treatment time range will not raise any safety or effectiveness issue.

### Note 3:

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 "Frequency range" and "Pulse width range" of the proposed device are a little different from the predicate device, but they are all compliance with IEC 60601-2-10 requirements. So, the minor differences of function will not raise any safety or effectiveness issue.

### Note 4:

The "Net Charge" and "Maximum Phase Charge" of the proposed device are very similar to the predicate device, and both of them comply with IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.

The maximum average current of the proposed device is smaller than that of the predicate device which means the better safety. The maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. However, the Maximum current density complies with IEC 60601-2-10 requirements and the

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows a logo for a company called JIA JIAN. The logo is in blue and features the company name in large, bold letters. There is a check mark above the letters. Below the company name is the company name in Chinese characters.

Maximum average power density is within 0.25W/cm2 limit.Therefore, these differences will not raise any new safety and effectiveness issues.

#### Final conclusion:

The proposed device TENStem eco basic is substantial Equivalent to the predicate device K112288.

#### 4. Non-Clinical Test Conclusion

Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator 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:

### 5. Clinical Test

Clinical data was not including in this submission.

#### 6. Conclusions

The conclusions drawn from the non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device.