FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLAIN JANE SERIES WHEELCHAIR
K Number: K842232
·
Decision Jun 22, 1984
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
111
Review Days
17
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Basic Information
- Device Name
- PLAIN JANE SERIES WHEELCHAIR
- K Number
- K842232
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Invacare Corp.
- Date Received
- June 5, 1984
- Decision Date
- June 22, 1984
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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ICON 35; ICON 45; ICON 60; ICON 30FAF
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FDA 510(k)
FDA Class 1
·Physical Medicine
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