The model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Device Description

The Well Life TENS devices, WL-2407 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

WL-2407 is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:

<1> The stimulation electrode is dual channels electrode.

<2> The output waveform is selectable pre-programming change among P1~P8.
<3> The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switching ON.
<4> The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, time to cut-off, and battery low warning.

AI/ML Overview

The provided 510(k) summary for the Well Life Healthcare Limited OTC TENS for Low Back Pain Relief / Model: WL-2407 (K063660) does not contain detailed information about specific acceptance criteria, a clinical study proving device performance against those criteria, or the methodology typically used for such studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance).

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (WL-2402 K040512, and WL-2406 K052785). The "study" referenced in the document is a comparison to these predicate devices and non-clinical testing.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is absent:

Acceptance Criteria and Device Performance Study

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., pain reduction scores, specific levels of electrical output accuracy, or patient satisfaction thresholds). Instead, the "acceptance criteria" are implied by demonstrating:

Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
Software verification: Carried out according to FDA software guidance.
Substantial Equivalence: The primary "acceptance criterion" for this 510(k) pathway is that the device has the same intended use and similar technological characteristics, and that any differences do not affect intended use or alter fundamental scientific technology compared to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implied)	Reported Device Performance
Intended Use Equivalence: Temporary relief of pain associated with sore and aching muscles in the lower back.	WL-2407 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Matches predicate device's use).
Technological Characteristics Equivalence: Similar features and operational principles to predicate devices.	Similarities identified: OTC TENS device. Differences identified: Selectable dual channel, 4.5V (3xAA/Alkaline battery) operated. Output waveform selectable pre-programming change (P1~~P8). Output strength adjustable 0~~80 mA. Setting time 21 minutes. LCD display for status.
Safety and Effectiveness Equivalence: Any engineering differences do not affect safety or effectiveness.	"Verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
Compliance to Voluntary Standards: Adherence to relevant electrical and medical device standards.	"Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement."
Software Verification: Complies with FDA software guidance.	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."

Detailed Information Regarding the "Study" (Comparison to Predicate Devices and Non-Clinical Testing)

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of a clinical test set in this submission. The "test set" in this case refers to the technical specifications and performance data of the WL-2407 device itself, which were compared against the specifications and established performance of the predicate devices.
Data Provenance: The document does not specify the origin of any clinical data (e.g., country) because a clinical study with human subjects validating the device's efficacy was not conducted or presented. The data provenance primarily relates to the technical specifications and verification/validation testing performed on the device itself. This would be considered "prospective" in the sense that the testing was performed on the WL-2407.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing. There was no "ground truth" derived from expert consensus on human data for a device performance test set. The efficacy of the predicate devices in relieving pain (the "ground truth" of performance) was previously established through their own clearance process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication of findings was described in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device (TENS unit) and not an algorithm with standalone performance metrics. Its performance is inherent to its electrical stimulation capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the equivalence claim: The "ground truth" for the WL-2407's efficacy is the established safety and effectiveness of its predicate devices (WL-2402 K040512 and WL-2406 K052785) for the same intended use.
For non-clinical testing: The "ground truth" would be objective measurements against established engineering standards (e.g., electrical output parameters, safety features) as per ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.

In summary: K063660 is a 510(k) submission for a TENS device seeking clearance based on substantial equivalence to existing predicate devices. The "study" described is primarily a comparison of the new device's technical characteristics and intended use to the cleared predicates, supported by non-clinical verification and validation testing against recognized standards. It does not involve a clinical study with human subjects, nor does it pertain to AI or diagnostic software.

Summary

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K063660

510(K) Summary

7 2007 FEB

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Submitter's Identifications: Well Life Healthcare Limited 5FI., Ste 504, Empire Centre, 68 Mody Road, Tsimshatsuim, Kowloon, Hong Kong
  Contact: Jenny Hsieh

Date of Summary Preparation: January 31, 2007.

2. Name of the Device:

OTC TENS for Low Back Pain Relief / Model: WL-2407.

1. Information of the 510(k) Cleared Device (Predicate Device):
  WL-2402 (K040512), and WL-2406 (K052785).

4. Device Description:

WL-2407 is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:

<1> The stimulation electrode is dual channels electrode.

<2> The output waveform is selectable pre-programming change among P1~P8.
<3> The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switching ON.
<4> The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, time to cut-off, and battery low warning.

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5. Intended Use:

The model WL-2407 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities

The standard format for the statement of indications and contraindication for use are provided hereafter.

6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

7. Conclusions

The OTC TENS for low back pain relief/ model WL-2407 has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K040512), and WL-2406 (K052785). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Well-Life Healthcare Limited % Ms. Jenny Hsieh 68 Mody Road, Empire Centre, Suite 504 Tsimshatsuim, Kowloon Hong Kong

7 2007 FEB

Re: K063660

Trade/Device Name: OTC TENS for Low Back Pain Relief/Model WL-2407 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH Dated: December 6, 2006 Received: December 8, 2006

Dear Ms. Hsieh:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jenny Hseih

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: OTC TENS For Low Back Pain Relief / Model WL-2407.

Indications For Use:

The model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Prescription Use OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Conci of Of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices 1063660

510(k) Number_

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).