Mattress And Bed Deck Cover (Medical Purposes)
The Mattress and Bed Deck Cover for Medical Purposes is a device intended to provide a physical barrier between a patient and the mattress as well as all or parts of the bed deck or frame, protecting the patient from contamination, pressure injury risks, or other environmental factors associated with the bed surface. Classified as FDA Class 1 under regulation 880.6190, it is subject to general controls only and is 510(k) exempt in the General Hospital specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTV
- Device Class
- FDA class 1
- Regulation Number
- 880.6190
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201876 | Soteria Bed Barrier | Sep 01, 2022 | Substantially Equivalent | Trinity Guardion |
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.