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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2020]
[CITE: 21CFR880.5150]
See Related Information on Nonpowered flotation therapy mattress. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart F - General Hospital and Personal Use Therapeutic Devices

Sec. 880.5150 Nonpowered flotation therapy mattress.

(a) Identification. A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

(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 § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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