Indications For Use (Available for WL-2203 & 'TENS function' of WL-2205): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204 & 'EMS function' of WL-2205): - 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-2203, WL-2204, and WL-2205 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-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator 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 a Transcutaneous Electrical Nerve Stimulation Device (TENS) called Digi-Pro TENS, but does not contain any information about acceptance criteria or a study proving its performance against acceptance criteria.

The document primarily focuses on:

Submitter's Identification: Well-Life Healthcare Inc.
Device Name: Well-Life TENS (Digi-Pro TENS series, including WL-2203, WL-2204, WL-2205).
Information of the 510(k) Cleared Device (Predicate Device): Refers to Part 6, which is not provided.
Device Description: Explains the basic function of the TENS device (stimulus generator, electrode, adjustable output/waveform, different operation modes via microprocessor control).
Intended Use: Mentions that intended uses and contraindications are defined in the instruction manual and also provides a standard format for indications for use for different models (WL-2203 and the "TENS function" of WL-2205 for chronic intractable pain relief; WL-2204 and the "EMS function" of WL-2205 for muscle spasms, disuse atrophy, blood circulation, muscle re-education, post-surgical calf stimulation, and range of motion).
FDA Communication (K020314): A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, classifying the device as Class II (Powered muscle simulator), and outlining general controls and regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them based on the text provided. The document is a 510(k) summary for regulatory clearance, not a clinical or performance study report.

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: _______________________________________________________________________________________________________________________________________________

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: December, 2001.

1. Name of the Device:
  Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205.
1. Information of the 510(k) Cleared Device (Predicate Device): Please see the information provided in part 6 of this summary.

4. Device Description:

Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator 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.

5. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tony C.S. Chang Well-Life Healthcare Inc. C/o Wincent Consultant No. 5. Allev 5. Lane Cheng Hsing Chung Ching Road, Pei Tun Dist. Taichung, Taiwan, R.O.C.

APR 30 2007

Re: K020314

Device Name: Digi-Pro TENS models WL-2204 and WL-2205 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle simulator Regulatory Class: Class II Product Code: IPF Dated: January 18, 2002 Received: January 30, 2002

Dear Mr. Tony 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 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

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Page 2 - Mr. Tony Chang

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This production volta on verin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The 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 additionally 21 Of Crair on Additionally, for questions on the promotion and advertising of your Occipitalies at (over of Compliance at (301) 594-4639. Also, please note the do nov, proase tool "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on the formation on your responsibilities under the Act may be obtained from the Ouvision 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 M Melleusen

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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Page

510(k) Number (if known):

Device Name:__Digi-Pro TENS / Model: WL-2203, WL-2204, WL-2205

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

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

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

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)
for Mark n Millenn
(Division Sign-Off)
(Optional Format 3-10-98)
Division of General, Restorative
and Neurological Devices
510(k) Number. K020314

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).