FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERMOBIL HEXIOR
K Number: K870228
·
Decision Feb 10, 1987
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
5
Review Days
20
Basic Information
- Device Name
- PERMOBIL HEXIOR
- K Number
- K870228
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- PERMOBIL OF AMERICA
- Date Received
- January 21, 1987
- Decision Date
- February 10, 1987
- 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