FORTE, MODELS CPS 400 STIM, CPS 200 STIM

K982828 · Chattanooga Group, Inc. · IPF · Nov 6, 1998 · Physical Medicine

Device Facts

• Record ID: K982828
• Device Name: FORTE, MODELS CPS 400 STIM, CPS 200 STIM
• Applicant: Chattanooga Group, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For VMS, Russian, Monophasic Hi-Volt - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis 1 For Microcurrent. Interferential and Premodulated - Symptomatic relief of chronic, intractable pain - Management of pain associated with post-traumatic or post-operative conditions

Device Story

Forte CPS series (200/400 Stim, Ultrasound, Combo) are therapeutic electrotherapy and ultrasound devices. Inputs: electrical signals for stimulation; ultrasonic energy for therapeutic heating/tissue effects. Operation: clinician-controlled delivery of VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, and Premodulated currents; ultrasound therapy. Used in clinical settings by physicians or physical therapists. Output: electrical stimulation pulses or ultrasonic waves applied to patient skin via electrodes or transducers. Clinical benefit: pain management, muscle rehabilitation, and circulation improvement. Device assists clinicians in physical therapy and pain management protocols.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-modality electrotherapy and ultrasound system. Modalities: VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, Premodulated, and Ultrasound. Energy source: AC power. Form factor: clinical console/desktop unit. Connectivity: standalone. Sterilization: not applicable (external use).

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, range of motion maintenance, or prevention of venous thrombosis (via calf stimulation). Also indicated for patients requiring symptomatic relief of chronic, intractable pain or management of post-traumatic/post-operative pain.

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

6 1998 NOV

Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

Re : K982828 Forte CPS 400 Stim and Forte CPS 200 Stim Trade Names: Product Codes: GZJ, LIH, and IPF K982829 Forte CPS Ultrasound Trade Name: Product Code: IMI K982830 Forte CPS 400 Combo and Forte CPS 200 Combo Trade Names: Product Codes: GZJ, LIH, IPF, IMG, and IMI Regulatory Class: II August 10, 1998 Dated: Received: August 11, 1998

Dear Mr. Elrod:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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

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Page 2 - Mr. Joe Elrod

In addition, FDA may publish further announcements action. concerning your devices 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 requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

Colin M. Wittchen, Ph.D., M

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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## CHATTANOOGA GROUP, INC.

## STATEMENT OF INDICATIONS FOR USE

For VMS, Russian, Monophasic Hi-Volt

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis 1

For Microcurrent. Interferential and Premodulated

- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions

Prescription Use
(Per 21 CFR 801.109)

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(Division Sign-Off) Division of General Restorative Devices K982828 510(k) Number _

4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: [phone] Fax: [phone]