FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTREME 4X4-X8 POWER WHEELCHAIR
K Number: K090350
·
Decision Apr 10, 2009
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
6
Review Days
58
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Basic Information
- Device Name
- EXTREME 4X4-X8 POWER WHEELCHAIR
- K Number
- K090350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vestil Manufacturing Corp.
- Date Received
- February 11, 2009
- Decision Date
- April 10, 2009
- 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 Vestil Manufacturing Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030783 | FRONTIER MODEL X5 | Apr 4, 2003 | Substantially Equivalent |
| K021866 | KARMA 800 SERIES MANUAL WHEELCHAIR | Jun 14, 2002 | Substantially Equivalent |
| K014127 | KARMA DISCOVERY, MODEL KP40 | Mar 15, 2002 | Substantially Equivalent |
| K011374 | JEWEL MPS | May 29, 2001 | Substantially Equivalent |
| K000796 | MAGIC MOBILITY 4 X 4 WHEELCHAIR | Aug 11, 2000 | Substantially Equivalent |