FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUALINE WHEELCHAIR PRODUCTS
K Number: K843213
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
23
Applicant Total
1
Review Days
9
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Basic Information
- Device Name
- QUALINE WHEELCHAIR PRODUCTS
- K Number
- K843213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Contemporary Health Sys
- Date Received
- August 15, 1984
- Decision Date
- August 24, 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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