(239 days)
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
-
Relief of pain, muscle spasms and joint contractures
-
Relief of pain, muscle spasms and joint contractures that may be associated with:
a) Adhesive capsulitis
b) Bursitis with slight calcification
c) Myositis
d) Soft tissue injuries
e) Shortened tendons due to past injuries and scar tissues
- Relief of sub-chronic and chronic pain and joint contractures resulting from:
a) Capsular tightness
b) Capsular scarring
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Vectra (Intelect) Genisys Ultrasound." It outlines the device's classification, intended use, and confirms its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study that proves the device meets such criteria.
The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment, is typically found in premarket submission documents (like the 510(k) itself or associated test reports), not in the FDA's clearance letter. The clearance letter only states that the FDA reviewed the submission and found the device substantially equivalent based on the information provided by the manufacturer.
§ 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.