OSI
- Product code
- OSI
- Device name
- Bariatric Bed
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5100
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K) Exempt
FDA classification definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Official FDA classification page: OSI
Classification and pathway per current FDA publications. Data from openFDA (CC0).