Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B): - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion.

Device Description

The Digi-Pro TENS series, including WL-2203B, WL-2204B-P1, WL-2204B-P1, WL-2204B-P2, and WL-2205B are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B, consist mainly of two parts: the stimulus generator, electrode. The stimulus qenerator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

AI/ML Overview

The provided text describes a 510(k) summary for the Well-Life TENS device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo effectiveness study with specific acceptance criteria and performance metrics against a ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as there wasn't an independent effectiveness study performed in the way an AI/ML device would typically undergo.

Here's why the requested information isn't present:

Acceptance Criteria and Reported Device Performance: This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). Its clearance is based on substantial equivalence to existing TENS/PMS devices (K021359 & K020314, SD603/Model III, SD-605/program and Q-MS). The "acceptance criteria" here are that the new device's technical specifications and safety features are comparable to the predicate devices and meet relevant electrical safety standards (e.g., ANSI/AAMI, EN 60601 series). There are no specific quantitative "performance" metrics (like accuracy, sensitivity, or specificity common in AI/ML studies) reported in this summary.
Sample Size and Data Provenance for Test Set: Not applicable. There was no clinical "test set" in the context of an effectiveness study for this 510(k). The evaluation focused on engineering performance and substantial equivalence to predicates.
Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or efficacy outcomes, was not established for a clinical effectiveness study.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device, so no such study was performed or is relevant.
Standalone Performance: Not applicable as there is no "algorithm" in the modern AI sense. The device's "standalone" performance is its electrical output and safety characteristics, which were assessed against standards and predicate device specifications.
Type of Ground Truth: Not applicable. The ground truth for this type of device regulatory submission is compliance with established electrical safety and performance standards for therapeutic devices, and demonstration that its technical characteristics are consistent with predicate devices that have prior clearance for their intended uses.
Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in that context.
How Ground Truth for Training Set was Established: Not applicable.

What the document does describe in terms of performance and testing:

Non-Clinical Tests: Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
Software Verification: Carried out according to FDA software guidance.
Conclusion: Verification and validation tests demonstrate that differences in the submitted models maintain the same safety and effectiveness as the cleared predicate devices, and do not affect the intended use or alter the fundamental scientific technology.

Summary

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K03053.7

510(K) SUMMARY

MAR 20 2003

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 Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei, Taiwan, R.O.C.
  Contact: Ms. Grace Chang Sales Manager

Date of Summary Preparation: February 11, 2003.

1. Name of the Device:
  Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model Digi-Pro TENS series, including WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B,
1. Information of the 510(k) Cleared Device (Predicate Device): K021359 & K020314.

4. Device Description:

Digi-Pro TENS series, models WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B, consist mainly of two parts: the stimulus generator, electrode. The stimulus qenerator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

1. Intended Use:
  On the instruction manual of each model, the intended uses and contraindication are defined very clearly. Please see the information of instruction manuals in clause 7.6 of this submission document.

In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.

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Well-Life Healthcare Inc.

Page_1__of__1_________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Digi-Pro TENS / Model: WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B.

Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B):

Relaxation of muscle spasms. .
Prevention or retardation of disuse atrophy. ●
Increasing local blood circulation. ●
. Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. ●
Maintaining or increasing range of motion. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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Well-Life Healthcare Inc.

1. Comparison to the 510(k) Cleared Device (Predicate Device)
- (1) The new model WL-2203B is substantially equivalent to the Well-Life clear model Wil-2203 (K021359).
- (2) The new model WL-2204B, 2204B-P1, and 2204B-P2 are substantially equivalent to the Well-Life clear model WL-2204 (K020314).
- (3) The new model WL-2205B is substantially equivalent to the Well-Life clear model Wt.-2205 (K021359 & K020314).
1. 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, EN 60601-1-1, 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.

8. Conclusions

The Digi-Pro TENS series, including WL-2203B, WL-2204B-P1, WL-2204B-P1, WL-2204B-P2, and WL-2205B, have the same intended use and technological characteristics as the cleared device of SD603/Model III, SD-605/program and Q-MS. 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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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right, with three lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Well-Life Healthcare, Inc. C/O Tony C.S. Chang Wincet Consultant Co., Ltd. No. 5, Alley 5, Lane Cheng Hsing Chung Ching Rd., Pei Tun District Taichung, Taiwan, R.O.C.

Re: K030537

Trade/Device Name: Digi-Pro TENS Model WL-2203B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ

Trade/Device Name: Digi-Pro TENS Models WL-2204B, WL-2204B-P1 and WL-2204B-P2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Trade/Device Name: Digi-Pro TENS Model WL-2205B Regulation Number: 21 CFR 882.5890 and 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator and Powered Muscle Stimulator Regulatory Class: Class II Product Code: GZJ and IPF

Dated: February 11, 2003 Received: February 20, 2003

Dear Mr. 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.

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Page 2 -- Mr. Tony C.S. Chang

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark N Milkus

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Well-Life Healthcare Inc.

Page 1 _of_1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Digi-Pro TENS / Model: WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B.

Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B):

Relaxation of muscle spasms. ●
Prevention or retardation of disuse atrophy. .
Increasing local blood circulation. .
Muscle re-education. ●

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. ●
Maintaining or increasing range of motion. .

Mark N. Milkersen

Resto rive

710(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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).