21 CFR 890.3175 — Cushion, Flotation

Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3175

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KICCushion, Flotation129
Innolitics

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