FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GEL FLOTATION CUSHION
K Number: K813225
·
Decision Dec 3, 1981
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
4
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GEL FLOTATION CUSHION
- K Number
- K813225
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Jefferson Industries, Inc.
- Date Received
- November 10, 1981
- Decision Date
- December 3, 1981
- Product Code
- KIC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KIC | Cushion, Flotation | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIC), ordered by most recent decision date.
GEL-T CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
PROTEAM CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
CUSTOMCARE SEATING SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
MULTICURE(R) S GEL PAD
FDA 510(k)
FDA Class 1
·Physical Medicine
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
GEL CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine