OSI — Bariatric Bed Class II
FDA product code OSI covers "Bariatric Bed", a Class II medical device regulated under 21 CFR 880.5100. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- OSI
- Device Class
- Class II
- Regulation Number
- 880.5100
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.