Product Code: MOC
FDA class 2
21 CFR 890.5170
Cushion, Flotation, Therapeutic
Physical Medicine
The Therapeutic Flotation Cushion is a physical medicine device designed to distribute pressure evenly across the seating surface, reducing the risk of pressure ulcers in patients who sit for extended periods. Classified as FDA Class 2 under 21 CFR 890.5170 in the Physical Medicine specialty, it requires 510(k) premarket notification. The product code is MOC.
510(k)s
2
FEI Numbers
4
Registration Numbers
4
Unique Applicants
2
Years Active
12
Basic Information
- Product Code
- MOC
- Device Class
- FDA class 2
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.