510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSIClass II

Bariatric Bed

21 CFR 880.5100 / General Hospital
FDA source (opens on fda.gov)

OSI is the FDA product code for Bariatric Bed, a class II device type, regulated under 21 CFR 880.5100. FDA's definition for this code reads: "A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width". As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
OSI
Device name
Bariatric Bed
FDA definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order