21 CFR 890.3175
§ 890.3175 Flotation cushion.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3175, § 890.3175 Flotation cushion, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91177
- Permanent ID
ys:prov:91177@1- SHA-256
7996a1feeed269683ed5a1ad7adb0e37d76ae410dd2c09d7785fad7a9bf3b934
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.