FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROLLCHAIR, ORTHO BUCKET SEAT
K Number: K790560
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
34
Applicant Total
51
Review Days
22
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
- ROLLCHAIR, ORTHO BUCKET SEAT
- K Number
- K790560
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Maddak, Inc.
- Date Received
- March 19, 1979
- Decision Date
- April 10, 1979
- 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 Maddak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841700 | WALK & ROLL | May 11, 1984 | Substantially Equivalent |
| K841695 | CRAWLER | May 10, 1984 | Substantially Equivalent |
| K841698 | HEAT PACK | May 10, 1984 | Substantially Equivalent |
| K841697 | HYDRO-THERO PAD | May 9, 1984 | Substantially Equivalent |
| K841692 | PRONE STANDER | May 9, 1984 | Substantially Equivalent |
| K841691 | SPLIT SEAT POSITIONING CHAIR | May 9, 1984 | Substantially Equivalent |
| K841693 | STANDING FRAME | May 9, 1984 | Substantially Equivalent |
| K834311 | NIGHT TRAINER | Mar 30, 1984 | Substantially Equivalent |
| K833870 | KNEE WALKER | Nov 29, 1983 | Substantially Equivalent |
| K833177 | GLOSSECTOMY FEEDING SPOONS | Oct 31, 1983 | Substantially Equivalent |