IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND

K024100 · Theratech, Inc. · LIH · Feb 25, 2003 · Neurology

Device Facts

• Record ID: K024100
• Device Name: IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
• Applicant: Theratech, Inc.
• Product Code: LIH · Neurology
• Decision Date: Feb 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

Device Story

WL-2206 is an interferential stimulator generating small real-sine electrical current pulses; delivered to patient skin via cables and electrodes. Device relieves chronic and/or acute pain through nerve stimulation. Operated in clinical or home settings; used by patients under prescription. Healthcare providers use output to manage pain symptoms; device provides non-pharmacological pain relief benefit.

Clinical Evidence

Bench testing only. Compliance with voluntary standards (ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2) and software verification per FDA guidance.

Technological Characteristics

Interferential stimulator; generates real-sine electrical current pulses. Connectivity: wired electrodes. Standards: ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2. Software verification performed.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients requiring TENS-like stimulation.

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

• IF-400 (k930535)
• IF-4000 (k952683)

Submission Summary (Full Text)

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Theratech, Inc.

#### 510(K) SUMMARY

Ko24100

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: _______________________________________________________________________________________________________________________________________________

FEB 2 5 2003

- 1. Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Contact: Mr. Mike Price

Date of Summary Preparation: September, 2002.

- 2. Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206, Well IF, Life IF and the customer private brand.

- 3. Information of the 510(k) Cleared Device (Predicate Device):
IF-400 (k930535) and IF-4000 (k952683).

- 4. Device Description:
The WL-2206 is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

- 5. Intended Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

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

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### 510(K) SUMMARY

### 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, 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.

### 7. Conclusions

The true sine interferential stimulator, model WL-2206, has the same intended use and technological characteristics as the cleared device of IF-400 (k930536), and IF-4000 (k952683). 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 is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined snakes and a staff, representing healing and medicine. The seal is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

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: K024100

Trade/Device Name: IF series True sine interferential stimulator models: WL-2206, Well IF, and Life IF Regulation Number: Unclassified Regulation Name: Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: December 6, 2002 Received: December 12, 2002

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.

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

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Page 2 – Mr. Tony C.S. 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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milliman

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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Theratech, Inc.

## 510(K) SUMMARY

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: JF series True sine interferential stimulator / Model: WL-2206, Well IF, Life IE and the customer private brand.

# Indications For Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

Mila N. Millikan

1. Restmative Ugar at the lees

(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> |
|----------------------|--------------|
| OR | |
| Over-The-Counter Use | |

(Optional Format 1-2-96)