IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A

K050847 · Theratech, Inc. · IPF · Jun 17, 2005 · Physical Medicine

Device Facts

• Record ID: K050847
• Device Name: IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
• Applicant: Theratech, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• 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 WL-2206A is an interferential stimulator that generates small real-sine electrical current pulses. The device delivers these pulses to the patient's skin via cables and electrodes to stimulate underlying nerves for the relief of chronic or acute pain. It is intended for use by healthcare professionals or patients under prescription. The device functions by applying electrical stimulation to the target area, which is intended to manage pain symptoms. It is a clinical or home-use device that provides symptomatic relief for chronic intractable pain.

Clinical Evidence

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

Technological Characteristics

Interferential stimulator generating real-sine electrical pulses. Complies with ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Includes software-controlled stimulation parameters.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• WL-2206 (k024100)

Submission Summary (Full Text)

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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: Ko50847

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

Date of Summary Preparation: March 2005.

#### 2. Name of the Device:

IF series True sine interferential stimulator / Model: WL-2206A.

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

WL-2206 (k024100) .

#### 4. Device Description:

The WL-2206A 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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# 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, 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-2206A, has the same intended use and technological characteristics as the cleared device of WL-2206 (k024100). Moreover, verification and validation tests contained in this submission Moronstrate 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter in a circular fashion. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

Public Health Service

JUN 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Price Official Correspondent Theratech Incorporated 1109 Myatt Boulevard Madison, Tennessee 37115

Re: K050847

Trade/Device Name: IF series True sine interferential stimulator / Model: WL-2206A Regulatory Class: Unclassified Product Code: IPF Dated: May 6, 2005 Received: May 20, 2005

Dear Mr. Price:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 I ou may, merclere, mains of the Act include requirements for annual registration, listing of general controls profitions 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. Mike Price

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of any of a lot a first and starticle spiralence of your device to a This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equipe of the pe premarket notification. The FDA Inding of backansa organity of the 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
rst lead If you desire specific advice for your de necessor of views note the regulation entitled, the regulation entitled, the contact the Office of Compulance at (210) 278 ation" (21CFR Part 807.97). You may obtain "Misbranding by relerence to peniance notification (the Act from the Division of Small)
other general information on your responsibilities under the Act from the 6800 638.00 other general information on your responsion installed on the enumber [phone] or 1980) of the Manufacturers, International and Consulter 11bostoner of carb/industry/support/index.html.

Sincerely yours,

Sincercly yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

1050844 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: JF series True sine interferential stimulator / Model: WL-2206A.

### Indications For Use:

The device is an interferential stimulator with TENS indications used for The device is an interferential stimatic intractable pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓ OR

Over-The-Counter Use __

Division of General, Restorative
and Neurological Devices (Optional Format 1-2-96)

K050847