(43 days)
The Air Compression Recovery System is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an "Air Compression Recovery System." It discusses regulatory aspects, such as classification, general controls, quality system regulations, and adverse event reporting.
However, it does not contain any details about clinical studies, performance data, acceptance criteria, sample sizes for training or test sets, ground truth establishment, or expert involvement in product validation. The letter solely confirms the device's substantial equivalence to predicate devices and outlines the regulatory obligations of the manufacturer.
§ 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).