FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
P & F POWER WHEELCHAIR, MODEL HC-500SB
K Number: K082722
·
Decision Oct 28, 2008
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
2
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- P & F POWER WHEELCHAIR, MODEL HC-500SB
- K Number
- K082722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- P & F Brother Ind., Corp.
- Date Received
- September 17, 2008
- Decision Date
- October 28, 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 (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by P & F Brother Ind., Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K070350 | P&F POWER WHEELCHAIR, HC-510 | Mar 14, 2007 | Substantially Equivalent |