IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2

K060975 · Theratech, Inc. · LIH · May 10, 2006 · Neurology

Device Facts

• Record ID: K060975
• Device Name: IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
• Applicant: Theratech, Inc.
• Product Code: LIH · Neurology
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Special
• 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

The IF series (Models WL-2206A1 and WL-2206A2) is an interferential stimulator that generates true-sine electrical current pulses. The device delivers these pulses to the patient's skin via cables and electrodes to provide pain relief. It is intended for the management of chronic intractable pain. The device is operated by healthcare providers or patients in a clinical or home setting. The output is controlled electrical stimulation, which modulates nerve activity to alleviate pain symptoms.

Clinical Evidence

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

Technological Characteristics

Interferential stimulator generating true-sine electrical pulses. Complies with ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Connectivity is via cable and skin electrodes. Software verification performed per FDA guidance.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients requiring TENS-based electrical 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

• WL-2206A (K050847)

Submission Summary (Full Text)

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MAY 10 1005

# 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: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Contact: Mr. Mike Price

Date of Summary Preparation: March 2006.

## 2. Name of the Device:

IF series True sine interferential stimulator / Model: WL-2206A1 & WL-2206A2.

#### 3. Information of the 510(k) Cleared Device (Predicate Device):

WL-2206A (k050847) .

## 4. Device Description:

The WL-2206A1 and WL-2206A2 are the device which generates the small true-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 for the statement of indications and contraindication for use are provided hereafter.

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# 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as a 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 true sine interferential stimulator, model WL-2206A1 & WL-2206A2, has the same intended use and technological characteristics as the cleared device of WL-2206A (k050847). 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 stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 10 2006

Theratech, Inc. c/o Mr. Michael Price 1109 Myatt Blvd. Madison, Tennessee 37115

Re: K060975

Trade/Device Name: IF True Sine Interferential Stimulator Models WL-2206A1 and WL-2206A2 Regulatory Class: Unclassified Product Code: LIH Dated: March 27, 2006 Received: April 10, 2006

Dear Mr. Price:

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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Michael Price

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Herbert Semmering

N
DE

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: IF series True sine interferential stimulator / Model: WL-2206A1 and WL-2206A2.

Indications For Use:

...

... ..

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

Prescription Use V (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)

> Iffice of Device Evaluation (ODE) Concurrence of CDRI

Helder Remers nd
**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

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510(k) Number_K060975