FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POIRIER REGLADE WHEELCHAIR
K Number: K840630
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
23
Applicant Total
17
Review Days
38
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Basic Information
- Device Name
- POIRIER REGLADE WHEELCHAIR
- K Number
- K840630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Poirier S.A.
- Date Received
- January 20, 1984
- Decision Date
- February 27, 1984
- Product Code
- IQC
- 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 |
|---|---|---|---|
| IQC | Wheelchair, Special Grade | FDA class 2 | Physical Medicine |
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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 |
| 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 |