(150 days)
The Air Compression Therapy Device are indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device. It confirms substantial equivalence to a predicate device and states the indications for use. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria for device performance, the study that proves it meets those criteria, or the methodology of such a study.
The letter focuses on regulatory clearance based on substantial equivalence, and while it references labeling and good manufacturing practices, it doesn't describe the clinical or performance studies you're asking about. Such information would typically be found in the manufacturer's 510(k) submission summary or other technical documentation, not in the FDA's clearance letter itself.
Therefore, I cannot provide the requested information from the given input.
§ 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).