(331 days)
The SU-100 generates 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.
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This document is a 510(k) premarket notification decision letter from the FDA to SUN-RAIN System Corporation for their SUN-RAIN Ultrasonic Therapy Model SU-100. It states that the device is substantially equivalent to legally marketed predicate devices.
This document DOES NOT contain information regarding acceptance criteria, device performance, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of efficacy studies (such as MRMC or standalone performance).
The letter is a regulatory approval document based on the device's substantial equivalence to existing devices, not a study report detailing performance metrics against specific acceptance criteria.
The information provided only includes:
- Trade Name: SUN-RAIN Ultrasonic Therapy Model SU-100
- Regulation Number: 21 CFR 890.5300
- Regulation Name: Ultrasonic Diathermy
- Regulatory Class: Class II
- Product Code: IMI
- Indications for Use: The SU-100 generates 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.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy 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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy 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 that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues 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 ultrasonic diathermy 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 ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.