K Number

Device Name

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

Manufacturer

Wuxi Jiajian Medical Instrument Co., Ltd

Date Cleared

2023-01-24

(124 days)

Product Code

GZJ

Regulation Number

882.5890

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 Description

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. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K220578

Reference Devices

K192568

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard TENS device with pre-set and editable programs, powered by batteries or AC. There is no mention of AI, ML, or any adaptive or learning capabilities. The performance studies are limited to bench testing against electrical safety and performance standards.

Therapeutic

Yes
The device is indicated for use for "pain relief by applying an electrical current to electrodes on a patient's skin to treat pain" and specifically for "symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain," which are therapeutic applications.

Diagnostic

Explanation: The device is indicated for pain relief by applying an electrical current, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it comprises an "electronic stimulatory module and accessories of lead wires, electrodes," indicating it is a hardware device that delivers electrical current.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for pain relief by applying electrical current to the skin. This is a therapeutic application, not a diagnostic one.
Device Description: The device is an electrical nerve stimulator that applies current to the skin. It does not involve the examination of specimens derived from the human body (which is the core definition of an IVD).
Performance Studies: The performance studies focus on electrical safety and performance standards for nerve and muscle stimulators, not on the accuracy or reliability of diagnostic measurements.

IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates externally on the body for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GZJ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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:

Key Metrics

Not Found

Predicate Device(s)

K220578

Reference Device(s)

K192568

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K222879

Device Name

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

Indications for Use (Describe)

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
214116
	Contact:Wu Zhifang
	E-mail: doris.d@ceve.org.cn
	Tel: 86 510-88745788
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
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 Description:	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.
The device has 18 programs (13 standard programs and 5 editable
programs), powered by 6 pieces of 1.5V batteries or AC 100-240V,
comprising electronic stimulatory module and accessories of lead wires,
electrodes.
Six outlet sockets are used to connect skin electrodes by lead wires. The
accessories of electrodes is 510(k) cleared device (K192568), Size:
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

Parameters	New Device	Predicate Device	Comparison
510(k) Number	K222879	K220578	--
Device Name	Transcutaneous Electrical
Nerve Stimulator (model: TENS
WMPS6-1)	Transcutaneous Electrical
Nerve Stimulator (RJTENS-1)	--
Manufacturer	Wuxi Jiajian Medical
Instrument Co., Ltd	Bozhou Rongjian Medical
Appliance Co.,Ltd.	--
Intended use	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, 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.	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.	Same
Type of use	Prescription use	Prescription use	Same
Power Source(s)	DC9V(6×1.5V disposable
alkaline battery R14/UM2 type)
Power adapter:
Model:GTM96060-0612-3.0
Input:100-240V~,50/60Hz;
Output:DC9V,0.5A	1.5Vx4 AAA alkaline battery	Similar
Note 1
- Method of Line
Current Isolation	N/A	N/A	Same
- Patient Leakage
Current	--	--	--
- Normal
Condition (μΑ)

Single Fault
Condition (μA) | 2μA
NA | 2μA
NA | Same | |
| Average DC current
through electrodes
when device is on but
no pulses are being
applied (μΑ) |