Patient Bed With Canopy/Restraints
The Patient Bed with Canopy/Restraints is a general hospital device consisting of an enclosed bed canopy system used as a passive restraint to prevent patients from falling or exiting the bed. It is classified as Class 1 (FDA Class 1), subject to general controls, under regulation number 880.6760 in the General Hospital medical specialty. The product code is OYS and no 510(k) premarket notification is required for this device.
Research product code OYS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OYS
- Device Class
- FDA class 1
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
Enclosed bed canopy system used as passive restraint.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.