§ 890.3175 — Flotation Cushion

(a) Identification. A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.