FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHEELCHAIR ACCESSORIES
K Number: K840629
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
17
Review Days
38
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
- WHEELCHAIR ACCESSORIES
- K Number
- K840629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Poirier S.A.
- Date Received
- January 20, 1984
- Decision Date
- February 27, 1984
- Product Code
- KNN
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNN), ordered by most recent decision date.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY GC 12550 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY GC 12400 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY U1-33 AGM
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY U1-31 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
ALDEN LINEAGE WHEELCHAIR CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Poirier S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K840638 | PORTABLE TRANSIT CHAIR | Mar 16, 1984 | Substantially Equivalent |
| K840639 | POIRIER COMMODES | Mar 9, 1984 | Substantially Equivalent |
| K840636 | CHILDREN'S WHEELCHAIRS | Feb 27, 1984 | Substantially Equivalent |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840633 | AIRPORT WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840630 | POIRIER REGLADE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840626 | VERTICALIBRE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840631 | ARNAS WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840625 | UNION WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840632 | HEMIPLEGIC WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |