FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ORTHOFAB WHEELCHAIR
K Number: K952675
·
Decision May 7, 1996
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
7
Review Days
330
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Basic Information
- Device Name
- ORTHOFAB WHEELCHAIR
- K Number
- K952675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orthofab, Inc.
- Date Received
- June 12, 1995
- Decision Date
- May 7, 1996
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Orthofab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962565 | POWERED WHEELCHAIR | Mar 20, 1997 | Substantially Equivalent |
| K950903 | ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) | Apr 5, 1995 | Substantially Equivalent |
| K950904 | ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) | Apr 5, 1995 | Substantially Equivalent |
| K884812 | KARMA-RS, KARMA-FS WHEELCHAIRS | Dec 27, 1988 | Substantially Equivalent |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | Jan 24, 1986 | Substantially Equivalent |
| K852661 | APOLLO STERILE BLADES | Jul 11, 1985 | Substantially Equivalent |