The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.

Device Description

The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.

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

<1> The operation of device is via the connection of wire and electrode through the dual operation channels.
<2> The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
<3> The output waveform is selectable pre-programming change among P1-P6.
<4> The output strength is adjustable at 0~~80 mA, with setting time 5~~60 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

The provided 510(k) summary describes a TENS device (Transcutaneous Electrical Nerve Stimulator) and focuses on demonstrating its substantial equivalence to a previously cleared predicate device, rather than providing an independent study proving the device meets specific acceptance criteria through a clinical trial or detailed performance study.

Therefore, many of the requested sections (acceptance criteria table, sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth, ground truth establishment for training) cannot be fully populated from the provided document.

Instead, the submission relies on the successful clearance of the predicate device (WL-2402, K020020) and non-clinical tests to assert equivalence.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Same intended use as predicate device (WL-2402).	"The i. Pro TENS/ model WL-2407Rx has the same intended use... as the cleared device of WL-2402 (K020020)." Intended Use: "symptomatic relief of chronic intractable pain."
Technological Characteristics Equivalence: Similar technological characteristics to predicate device.	"similar technological characteristics as the cleared device of WL-2402 (K020020)." Specific characteristics listed for WL-2407Rx: dual channel, 4.5V, selectable pre-programming P1-P6, output 0-80mA, time 5-60 min, LCD display.
Safety and Effectiveness Equivalence: Differences do not affect safety or effectiveness compared to predicate device.	"verification and validation tests contained in this submission demonstrate that the difference... could maintain the same safety and effectiveness as that of cleared device." "those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."
Compliance to Applicable 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: Compliance with FDA software guidance.	"the software verification has been carried out according to the FDA software guidance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This submission is for substantial equivalence based on non-clinical testing and comparison to a predicate device, not a clinical study involving a test set of data or patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical test set requiring expert ground truth establishment is described.

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

Not Applicable. No clinical test set requiring adjudication is described.

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

No. This is a TENS device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation.

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

Not applicable. This TENS device is a physical medical device for pain relief, not an algorithm or software requiring standalone performance testing in that context. The "software verification" mentioned is likely for the embedded firmware controlling the device functions.

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

Not Applicable. The "ground truth" for this submission is adherence to engineering specifications, safety standards, and functional equivalence to the predicate device.

8. The sample size for the training set

Not Applicable. No training set for a machine learning algorithm is discussed.

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

Not Applicable. No training set for a machine learning algorithm is discussed.

Summary of the Study performed (as described in the 510(k)):

The "study" undertaken for the WL-2407Rx device to meet acceptance criteria was a demonstration of substantial equivalence to a predicate device (WL-2402, K020020). This involved:

Non-clinical tests: These included compliance with voluntary standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-2) and software verification according to FDA guidance.
Comparison of intended use and technological characteristics: The submission explicitly states the new device has "the same intended use and the similar technological characteristics" as the predicate.
Assertion of safety and effectiveness: The submission concludes that "verification and validation tests... demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

No human subjects studies, clinical trials, or expert-reviewed test sets were used or required for this 510(k) submission, as it falls under a Class II device and leverages the substantial equivalence pathway.

Summary

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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: _ _ 080304

1. Submitter's Identifications: Well-Life Healthcare Limited 1FL., No. 16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, Taiwan, R.O.C.
  Contact: Jenny Hsieh Phone No .: 886-2-2928-2112 Fax No.: 886-2-2928-1880 e-mail: jenny@welllifehealthcare.com.tw

Date of Summary Preparation: February 05, 2008

1. Name of the Device:
  i. Pro TENS / Model: WL-2407Rx.
1. Information of the 510(k) Cleared Device (Predicate Device):
  WL-2402 (K020020)

4. Device Description:

The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.

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

<1> The operation of device is via the connection of wire and electrode through the dual operation channels.
<2> The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
<3> The output waveform is selectable pre-programming change among P1-P6.
<4> The output strength is adjustable at 0~~80 mA, with setting time 5~~60 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.

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5. Intended Use:

The model WL-2407Rx TENS is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.

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 i. Pro TENS/ model WL-2407Rx has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K020020). 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.

Therefore; i. Pro TENS model WL-2407Rx is considered substantial equivalent to the 510(K) cleared model WK-2402(K020020).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2008

Well-Life Healthcare Limited % Ms. Jenny Hsieh 1FL., No. 16, Lane 454 Jungjeng Rd. Yunghe City, Taipei County, Taiwan, R.O.C.

Re: K080304

Trade/Device Name: Pro TENS, Model WL-2407 Rx Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 21, 2008 Received: June 4, 2008

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 r touse of acreased 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 or any x 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 rordly in the quality by eventy of Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jenny Hsieh

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark M. Millerson

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: i. Pro TENS / Model WL-2407Rx.

Indications For Use:

The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (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)

Nifke Dsh forman

(Division Division of General, Restorative, and Neurological Devices

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510(k) Number K080304

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).