CONTROL SOLUTIONS INC, MODEL CS3101

K993420 · Control Solutions, Inc. · IPF · Jul 19, 2000 · Physical Medicine

Device Facts

• Record ID: K993420
• Device Name: CONTROL SOLUTIONS INC, MODEL CS3101
• Applicant: Control Solutions, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circulation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Story

CS3101 Interferential Stimulator is a prescription-use device providing electrical stimulation therapy. It operates in two primary modes: Interferential Current Therapy for pain management and Neuro-Muscular Stimulation for muscle-related therapeutic applications. The device delivers electrical currents to the patient to achieve physiological effects such as muscle relaxation, increased circulation, and muscle re-education. It is intended for use by healthcare professionals in clinical settings. The output is controlled by the clinician to address specific patient symptoms or post-surgical recovery needs, aiding in pain reduction and physical rehabilitation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an interferential stimulator (Class II, Product Code: IPF). It functions as an electrical stimulator for pain management and neuromuscular stimulation. Technical specifications, materials, and specific software architecture are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic pain, management of post-surgical/post-traumatic pain, relaxation of muscle spasms, increased local blood circulation, maintenance/increase of range of motion, prevention/retardation of disuse atrophy, muscle re-education, and prevention of venous thrombosis via post-surgical calf muscle stimulation.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 9 2000

Mr. John Hayden Control Solutions, Inc. 508 West Fifth Avenue Naperville, Illinois 60563

Re: K993420

Trade Name: CS3101 Interferential Stimulator Regulatory Class: II Product Code: IPF Dated: May 16, 2000 Received: May 17, 2000

Dear Mr. Hayden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 - Mr. John Havden

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dma R. Lochner.

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;

K993420

Device Name:

CS3101 Interferential Stimulator

Indications For Use:

- . Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
- Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circu-. lation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danne R. Lochner

Dision Sign-Off) Orvision of General Restoration Devices 510(k) Number_K99342

Prescription Use 区 (Per 21 CFR 801.109)

OR

Over-The-Counter Use 0