(24 days)
The indications for use are:
- Relief or reduction of pain; 1.
- Reduction of muscle spasm; 2.
- Joint contracture; and 3.
-
- Local increase in circulation.
Modification to: Accusonic Plus, Model AP-100
The provided document is a 510(k) clearance letter from the FDA for a device called "Accusonic Plus, Model AP-100." This letter indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use (relief or reduction of pain, reduction of muscle spasm, joint contracture, and local increase in circulation).
However, the letter does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications. These types of details would typically be found in the 510(k) summary or the full submission, which are not provided here.
Therefore, I cannot fulfill your request with the given input. The information you are asking for is not present in this regulatory clearance letter.
§ 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.