(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.
§ 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.