(315 days)
No
The summary describes a standard TENS device with pre-set and editable programs, but there is no mention of AI or ML capabilities, data analysis, or learning algorithms.
Yes.
The device is indicated for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment, which are therapeutic uses.
No
Explanation: The provided text describes the device as a Transcutaneous Electrical Nerve Stimulator (TENS) used for symptomatic pain relief. While it's a medical device, its function is to provide therapy (electrical stimulation for pain relief) rather than to diagnose a condition.
No
The device description explicitly states it is a lithium battery-powered device comprising an electronic stimulatory module, lead wires, electrodes, and an adapter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment." This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The device description explains how it works by sending electrical current to nerves and muscles to relieve pain. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain.
The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter.
Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. 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;
• IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2024
Wuxi Jiajian Medical Instrument Co., Ltd % Doris Dong General manager Shanghai CV Technology Co., Ltd. Room 602, No.19 Dongbao Road, Songjiang Area, Shanghai. Shanghai 201613 China
Re: K231425
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: December 28, 2023 Received: December 28, 2023
Dear Doris Dong:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 D. Scott -S
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231425
Device Name
Transcutaneous Electrical Nerve Stimulator(TENS WMPS2-1)
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
| 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)
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
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K231425 |
|---|---|
| Date: | May 10, 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 | |
| E-mail: sch@jjmed.com.cn | |
| Tel: 86 510-88745788 | |
| Contactor: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, | |
| 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|---|---|
| Model: | TENS WMPS2-1 |
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can |
| be used for the symptomatic relief of chronic intractable pain, post | |
| traumatic pain adjunctive treatment, and post-surgical pain adjunctive | |
| treatment. | |
| Device Description: | Transcutaneous Electrical Nerve Stimulator sends gentle electrical current |
| to underlying nerves and muscle groups via electrodes applied onto the skin | |
| to relieve pain. | |
| The device has 16 programs (12 standard programs and 4 editable | |
| programs). It is a lithium battery-powered device comprising the electronic | |
| stimulatory module, the accessories of lead wires, the electrodes and the | |
| adapter. | |
| Two outlet sockets are used to connect skin electrodes by lead wires. The | |
| accessories of electrodes are 510(k) cleared devices (K192568). Size | |
| 50*50mm. |
4
3. Predicate Device Identification
| Predicate 510(k) Number: | K210223 |
|---|---|
| Marketing Clearance Date: | December 15,2021 |
| Product Name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Top-Rank Health Care Co.,Ltd. |
| Reference Predicate 510(k) Number: | K123958 |
| Marketing clearance date: | October 28,2013 |
| Product name: | Jiajian® Pointoselect Digital |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| Parameters | New Device | Predicate Device | Reference
Predicate Device | Comparison | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------|
| 510(k) Number | K231425 | K210223 | K123958 | -- | |
| Device Name | Transcutaneous
Electrical Nerve
Stimulator | Transcutaneous
Electrical Nerve
Stimulator | Jiajian® Pointoselect
Digital | -- | |
| Model | TENS WMPS2-1 | TOPTENS-01 | | -- | |
| Manufacturer | Wuxi Jiajian
Medical Instrument
Co., Ltd | Top-Rank Health
Care Co.,Ltd. | Wuxi Jiajian
Medical Instrument
Co., Ltd | -- | |
| Indications for use | Transcutaneous
Electrical
Nerve
Stimulator
(Model:TENS
WMPS2-1) can be
used
for
the
symptomatic relief
of chronic
intractable pain,
post traumatic pain
adjunctive
treatment,
and
post-surgical pain
adjunctive
treatment. | The TOPTENS-01
can be used for the
symptomatic relief
of chronic
intractable pain,
post traumatic pain
adjunctive
treatment, and
post-surgical pain
adjunctive
treatment. | Jiajian® Pointoselect
Digital is intended
for use in the
symptomatic relief
of chronic
intractable pain,
postoperative pain,
and acute pain. | Same | |
| Type of use | OTC | OTC | Prescription use | Same | |
| Power Source(s) | DC3.7 V Li-battery
powered | DC 4.5V, 3 AAA
batteries | DC 9V battery,
Type 6F22 | Similar
Note 1 | |
| - Method of Line
Current Isolation | N/A | N/A | N/A | Same | |
| - Patient Leakage
Current | -- | -- | -- | Same | |
| - Normal Condition | 2μA | 2μA | 20μA | | |
| (μΑ) | | | | | |
| - Single Fault
Condition (μΑ) | | N/A | N/A | N/A | |
| Average DC current
through electrodes
when device is on
but no pulses are
being applied (µA) | |