Bariatric Bed
The Bariatric Bed (product code OSI) is a hospital bed specifically designed for obese patients weighing 500 pounds or more. The bed is designed to expand from 38 to 60 inches in width to accommodate patients who cannot safely use standard hospital beds. As an FDA Class 2 device under regulation 880.5100, it requires 510(k) premarket clearance and falls within the General Hospital specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OSI
- Device Class
- FDA class 2
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.