CONTROL SOLUTIONS, INC., MODEL CS3102 HVG

K041146 · Control Solutions, Inc. · IPF · Jun 8, 2004 · Physical Medicine

Device Facts

• Record ID: K041146
• Device Name: CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
• Applicant: Control Solutions, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Relaxation of muscle spasm . Increasing local blood circulation . Maintaining or increasing range of motion • Preventing or retarding disuse atrophy . Muscle re-education . Intusion is outcales. . Federal law restricts this device to salc by or on the order of a practitioner so licensed by the law of the state in which he/she practices to use or order the use of the device.

Device Story

CS3102 High Voltage Galvanic Stimulator is a powered muscle stimulator used in clinical settings. Device delivers electrical stimulation to muscles to achieve therapeutic effects including spasm relaxation, improved circulation, range of motion maintenance, atrophy prevention, and muscle re-education. Operated by licensed practitioners. Output is electrical current applied to patient tissue. Benefits include physical rehabilitation and muscle function support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850). High voltage galvanic stimulation modality. Class II device.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, increased local blood circulation, maintenance or increase of range of motion, prevention or retardation of disuse atrophy, and muscle re-education. Prescription use only.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing, representing health and human services.

JUN - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Control Solutions, Inc. C/o Jeremi Peck Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

Re: K041146

K041140
Trade/Device Name: CS3102 High Voltage Galvanic Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 27, 2004 Received: May 28, 2004

Dear Mr. Peck:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bottom 3 rQtry pressed is substantially equivalent (for the indications felerenced above and nave actering gally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manage of the Medical Device American so to commerce provided in accordance with the provisions of the Federal Food, Drug, devices may been rechasined in assess asproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, market are act include requirements for annual registration, listing of general controls provisions of uactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class II (PMA), in If your device is classified (soc above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of this be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I D7 is issuation of a subside complies with other requirements of the Act that IDA has made a dotermination administered by other Federal agencies. You must of ally if ederal statutes and regarations and limited to: registration and listing (21 comply with an the rece stequirements, on ; good manufacturing practice requirements as set CFK Part 807), raoching (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Jeremi Peck

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA miding of basification of 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 If you desire specific advice for your don'ter at [phone]. Also, please note the regulation entitled, Colliact the Oriec of Complance at (21CFR Part 807.97). You may obtain Misbraining by reference to premainterial international on the Act from the Division of Small other general information on your response at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L Mark N Milkers

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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## Indications For Use

510(k) Number:

K041146

CS3102 High Voltage Galvanic Stimulator Device Name:

Indications For Use:

- Relaxation of muscle spasm .
- Increasing local blood circulation .
- Maintaining or increasing range of motion •
- Preventing or retarding disuse atrophy .
- Muscle re-education .
- Intusion is outcales. .

Federal law restricts this device to salc by or on the order of a practitioner so licensed by the law of the state in which he/she practices to use or order the use of the device.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II: NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div>(Division Sign-Off)</div> |
|--|------------------------------------------------------------|
| | Division of General, Restorative, and Neurological Devices |

| 510(k) Number | K041146 |
|---------------|---------|
|---------------|---------|

| Prescription Use <span style="font-size: 20px;">☑</span> | OR | Over-The-Counter Use <span style="font-size: 20px;">☐</span> |
|----------------------------------------------------------|----|--------------------------------------------------------------|
|----------------------------------------------------------|----|--------------------------------------------------------------|

(Per 21 CFR 801.109)