(42 days)
The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.
The Air Press simulates kneading and stroking of tissues by using an inflatable garment.
This document is a 510(k) clearance letter for the Telebrand Air Press Massager. It addresses the device's substantial equivalence to a legally marketed predicate device, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial details.
Therefore, I cannot provide the requested information. The letter primarily confirms that the FDA has reviewed the premarket notification and determined that the device can be marketed subject to general controls of the Federal Food, Drug, and Cosmetic Act.
§ 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).