21 CFR § 890.5650
Powered inflatable tube massager
June 25, 2020
(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).