(29 days)
The indications for use for the interferential therapy are:
- Relaxation of muscle spasm: 1.
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- Prevention or retardation of disuse atrophy:
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- Increasing local blood flow;
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- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent 5. venous thrombosis; and
- Maintaining or increasing range of motion. 6.
The indications for use for the ultrasound therapy are:
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- Relief or reduction of pain;
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- Reduction of muscle spasm;
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- Joint contracture; and
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- Local increase in circulation.
The indication for use for the combined therapy is:
- Reduction of muscle spasm. 1.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the Vectorsonic Model VU 270. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.
Specifically, the document:
- Identifies the device (Vectorsonic Model VU 270) and its manufacturer.
- States the regulation number, name, and regulatory class for the device (Ultrasound and muscle stimulator, Class II).
- Lists the indications for use for interferential therapy, ultrasound therapy, and combined therapy.
- Confirms the FDA's finding of substantial equivalence.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory approval, not a technical report detailing performance study results.
§ 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.