The model WL-2406 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.

Device Description

The Well Life TENS devices, WL-2406 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-2406 is a dual channel, 3V battery operated TENS device with the following features:

<1> The operation mode is "Wire" with dual channels.
<2> The stimulation electrode is connected via electrode belt for "Wire" operation mode.
<3> The output waveform is selectable pre-programming changed amonq P1~P8.
<4> The output strength is adjustable at 0~50 mA, with setting time 21 minutes counting from switching ON.
<5> 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

This a TENS device, and the information provided does not describe a study that uses a test set, ground truth, experts, or AI. Therefore, I will respond to the specific points based on the information available regarding non-clinical tests for medical devices.

Here's a breakdown of the acceptance criteria and how the device (WL-2406 TENS) met them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety	Compliance with:
Electrical Safety	- ANSI/AAMI, NS4-1985
Electromagnetic Compatibility	- EN 60601-1-2
General Medical Electrical	- EN 60601-1
Equipment Requirements
Effectiveness	Demonstrated substantial equivalence to the predicate device (WL-2402, K040512) in terms of intended use and technological characteristics. Verification and validation tests confirmed that engineering differences (e.g., dual channel, pre-programmed waveforms P1-P8, adjustable output strength 0-50mA, 21-minute timer, LCD display) do not affect intended use or alter the fundamental scientific technology, thereby maintaining the same safety and effectiveness as the cleared device.
Software Functionality	Software verification carried out according to FDA software guidance.
Intended Use	Model WL-2406 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. This matches the intended use of the predicate device and is appropriate for an OTC TENS device.
Technological Characteristics	The device's features (dual channel, "Wire" operation mode, electrode belt connection, selectable pre-programmed waveforms P1-P8, adjustable output strength 0-50 mA, 21-minute setting time, LCD display for status, output waveform, strength, time, and battery warning) were deemed similar enough to the predicate device that they did not affect safety or effectiveness. The differences were evaluated through verification and validation tests to ensure they maintained the same safety and effectiveness as the predicate.

The study that proves the device meets the acceptance criteria is described as "verification and validation tests" and a demonstration of "substantial equivalence" to a legally marketed predicate device (WL-2402, K040512).

Here's a breakdown of the requested information based on the provided text:

Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to a predicate device and compliance with voluntary standards for non-clinical testing. There is no mention of a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical outcomes or expert diagnoses in a clinical study. This submission focuses on non-clinical engineering and safety standards. The "experts" involved would be the engineers and regulatory specialists performing the verification and validation tests and assessing compliance with standards like ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Their qualifications are implicitly in their ability to conduct these standard tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no mention of a human-adjudicated test set in this 510(k) summary.
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 technology. It does not involve human readers interpreting cases or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for pain relief, not an algorithm. The "standalone" performance refers to the device's electrical and functional parameters as measured against engineering standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness is established through:
- Compliance with recognized voluntary standards: ANSI/AAMI NS4-1985 (electrical safety), EN 60601-1 (general medical electrical equipment), and EN 60601-1-2 (electromagnetic compatibility).
- Software verification: Though not explicitly detailed, compliance with FDA software guidance would involve verifying the software's functional requirements, design specifications, and safety measures.
- Substantial equivalence demonstration: The primary "ground truth" for marketing clearance is that the device is "as safe and effective" as a legally marketed predicate device. This is achieved by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness and that the intended use is the same.
The sample size for the training set: Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

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

510(K) Summary

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: K052785/S2

11 11 12

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: March 10, 2006.

1. Name of the Device:
  OTC TENS for Low Back Pain Relief / Model: WL-2406.
1. Information of the 510(k) Cleared Device (Predicate Device):
  WL-2402 (K040512).
1. Device Description:
  The Well Life TENS devices, WL-2406 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-2406 is a dual channel, 3V battery operated TENS device with the following features:
<1> The operation mode is "Wire" with dual channels.
<2> The stimulation electrode is connected via electrode belt for "Wire" operation mode.
<3> The output waveform is selectable pre-programming changed amonq P1~P8.
<4> The output strength is adjustable at 0~50 mA, with setting time 21 minutes counting from switching ON.
<5> 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.

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

5. Intended Use:

The model WL-2406 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.

ം. 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 quidance.

7. Conclusions

The OTC TENS for low back pain relief/ model WL-2406 has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K040512). 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.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the central image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2008

Well-Life Healthcare, Incorporated c/o Ms. Grace Chang 1FL, No. 16, Lane 454 Jungjeng Road., Yunghe City Taipei County, Taiwan, R.O.C.

Re: K052785

Trade/Device Name: Well-Life Model WL-2406 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Code: NUH Dated: February 14, 2006 Received: February 15, 2006

Dear Ms. Chang:

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 docs 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

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

Page 2 - Ms. Grace Chang

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 CHR 1000-1050. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Severin us

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

Enclosure

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

Indications For Use

510(k) Number (if known): K052785/S2

Device Name: OTC TENS For Low Back Pain Relief / Model WL-2406.

Indications For Use:

The model WL-2406 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 (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Spencer us

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K052785

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).