FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTABLE TRANSIT CHAIR
K Number: K840638
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
34
Applicant Total
17
Review Days
56
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Basic Information
- Device Name
- PORTABLE TRANSIT CHAIR
- K Number
- K840638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Poirier S.A.
- Date Received
- January 20, 1984
- Decision Date
- March 16, 1984
- 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 |
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Other Clearances by Poirier S.A.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K840629 | WHEELCHAIR ACCESSORIES | Feb 27, 1984 | Substantially Equivalent |
| K840632 | HEMIPLEGIC WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |