FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
K450 POWERED WHEELCHAIR
K Number: K081964
·
Decision Jul 29, 2008
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
6
Review Days
19
Basic Information
- Device Name
- K450 POWERED WHEELCHAIR
- K Number
- K081964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PERMOBIL AB
- Date Received
- July 10, 2008
- Decision Date
- July 29, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
Power Wheelchair (MOB1107)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (HG-630)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (D26)
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (F309)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by PERMOBIL AB
| K Number | Device Name | ||
|---|---|---|---|
| K143180 | F3 | Mar 27, 2015 | Substantially Equivalent |
| K143014 | F5 | Mar 25, 2015 | Substantially Equivalent |
| K123290 | M300 & M400 | Apr 17, 2013 | Substantially Equivalent |
| K103477 | PERMOBIL M300 / M400 | Mar 3, 2011 | Substantially Equivalent |
| K071650 | C350 POWERED WHEELCHAIR | Sep 12, 2007 | Substantially Equivalent |