FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOLDING SHOWER-COMMODE CHAIR
K Number: K802745
·
Decision Nov 19, 1980
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
34
Applicant Total
2
Review Days
16
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
- FOLDING SHOWER-COMMODE CHAIR
- K Number
- K802745
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Winco Winfield Co., Inc.
- Date Received
- November 3, 1980
- Decision Date
- November 19, 1980
- Product Code
- INM
- 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 |
|---|---|---|---|
| INM | Chair, With Casters | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INM), ordered by most recent decision date.
NISSIN PEDIATRIC SERIES WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
STRYKER 5050 STRECHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CAREMOR CLINER
FDA 510(k)
FDA Class 1
·Physical Medicine
RECLINING GERI CHAIRS W/CASTERS & LAP TRAY
FDA 510(k)
FDA Class 1
·Physical Medicine
BENCHES
FDA 510(k)
FDA Class 1
·Physical Medicine
CHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Winco Winfield Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802744 | FOLDING ROLL-ABOUT CHAIR | Nov 19, 1980 | Substantially Equivalent |