← FDA Medical Device Classifications
Bariatric Bed
OSI · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5100
Classification
- FDA Product Code
OSI- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.5100
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 29
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown