FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARROW XT POWERED WHEELCHAIR
K Number: K865072
·
Decision Jan 21, 1987
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- ARROW XT POWERED WHEELCHAIR
- K Number
- K865072
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ivacare Corp.
- Date Received
- December 29, 1986
- Decision Date
- January 21, 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 |
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Other Clearances by Ivacare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925534 | FULL/SEMI ELECTRIC HOME CARE BED | May 12, 1993 | Substantially Equivalent |