(59 days)
The Perfect Touch™ Air Massaging System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Perfect Touch™ simulates kneading and stroking of tissues by using an inflatable garment.
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This document is a 510(k) premarket notification from the FDA for a device called "Relaxor® Perfect Touch™ Air Massaging System". It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
The document is an approval letter, not a study report. It confirms the device's regulatory classification and allows it to be marketed, but it does not detail the technical performance data that would have been submitted as part of the 510(k) application.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided text.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).