(87 days)
For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis; bursitis with slight calcification, myositis and soft tissue injuries. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.
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
For Interferential, Microcurrent, and Premodulated:
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Not Found
This document is a 510(k) clearance letter from the FDA for several medical devices manufactured by Chattanooga Group, Inc. It states that the devices (Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo) are substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory clearance based on substantial equivalence, not a detailed technical report of performance testing.
Therefore, I cannot provide the requested information based on the input text. The input text focuses on regulatory approval, product codes, trade names, and intended uses, not on performance metrics, study designs, or ground truth establishment.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 now
Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489
Re : K982828 Forte CPS 400 Stim and Forte CPS 200 Stim Trade Names: GZJ, LIH, and IPF Product Codes: 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 requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, 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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CHATTANQOGA GROUP, INC.
STATEMENT OF INDICATIONS FOR USE
For Ultrasound
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis; bursitis with slight calcification, myositis and soft tissue injuries. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.
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
For Interferential, Microcurrent, 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)
Division Sign-Off)
510(k) Numb
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4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-870-7404
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.