T-TECH DIGITAL, MODEL WL-22XXA SERIES

K033857 · Well-Life Healthcare, Inc. · GZJ · Dec 19, 2003 · Neurology

Device Facts

• Record ID: K033857
• Device Name: T-TECH DIGITAL, MODEL WL-22XXA SERIES
• Applicant: Well-Life Healthcare, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

T-tech Digital TENS/EMS series (models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, WL-2205A) provides transcutaneous electrical nerve stimulation (TENS) for pain relief and/or powered muscle stimulation (EMS). Device consists of stimulus generator and electrodes attached to patient skin. Microprocessor-controlled software generates adjustable output currents and waveforms based on patient needs. Operated by clinician or patient (prescription required) to deliver electrical pulses. Output affects muscle/nerve tissue to achieve therapeutic goals like spasm relaxation or pain management. Benefits include improved circulation, muscle maintenance, and pain relief.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 standards. Software verification performed per FDA guidance.

Technological Characteristics

Microprocessor-controlled transcutaneous electrical nerve and muscle stimulator. Components: stimulus generator, electrodes. Connectivity: standalone. Standards: ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain (TENS function) and for muscle spasm relaxation, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical calf muscle stimulation to prevent venous thrombosis, and maintaining/increasing range of motion (EMS function). Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Well-Life WL-2203B (K030537)
• Well-Life WL-2204B (K030537)
• Well-Life WL-2204B-P1 (K030537)
• Well-Life WL-2204B-P2 (K030537)
• Well-Life WL-2205B (K030537)

Submission Summary (Full Text)

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K033857

## DEC 1 9 2003

## 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. Jenny Hsieh Sales Manager

Date of Summary Preparation: December 9, 2003.

- 2. Name of the Device:
Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model T-tech Digital TENS series, including WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A.

- 3. Information of the 510(k) Cleared Device (Predicate Device): K030537.
## 4. Device Description:

The T-tech Digital TENS series, including WL-2202A. WL-2204A. WL-2204A. WL-2204A-P1. WL-2204A-P2, and WL-2205A 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.

T-tech Digital TENS series, models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, 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 T-tech Digital 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 provided this submission document.

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

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- 6. Companson to the 510(k) Cleared Device (Predicate Device):
- (1) The new model WL-2202A and WL-2203A is substantially equivalent to the Well-Life clear model WL-2203B (K030537).
- (2) The new model WL-2204A, 2204A-P1, and 2204A-P2 are substantially equivalent to the Well-Life clear model WL-2204B, WL-2204B-P1, and WL-2204B-P2 (K030537).
- (3) The new model WL-2205A is substantially equivalent to the Well-Life clear model WL-2205B (K030537).
- 7 . 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 carned out according to the FDA software guidance.

- 8. Conclusions
The T-tech Digital TENS series, including WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, have the same intended use and technological characteristics as the cleared device of WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B. 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Jenny Hsiah Well-Life Healthcare, Inc. Room 6C01, No.5, Sec. 5, Hsin Yi Rd. Chung Ching Rd., Pei Tun District Taipei, Taiwan, R.O.C.

Re: K033857

Trade/Device Name: T-tech Digital Models WL-2202A and WL-2203A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ

Trade/Device Name: 7-tech Digital Models WL-2204A, WL-2204A-P1 and WL-2204A-P2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Trade/Device Name: T-tech Digital Model WL-2205A 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: Undated Received: December 11, 2003

Dear Ms. Hsiah:

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 - Ms. Jenny Hsiah

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours

Sincerely yours,

Mark N. Milliken

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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510(k) Number (if known):_

Device Name: T-tech Digital / Model: WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A.

Indications For Use (Available for WL-2202A, WL-2203A & 'TENS function' of WL-2205A):

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

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

- · 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)

Prescription Use √

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Number: K033857