FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKIE P100 SERIES
K Number: K963382
·
Decision Apr 28, 1997
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
6
Review Days
244
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Basic Information
- Device Name
- QUICKIE P100 SERIES
- K Number
- K963382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quickie Designs, Inc.
- Date Received
- August 27, 1996
- Decision Date
- April 28, 1997
- 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 Quickie Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972230 | QUICKIE P90 SERIES | Dec 2, 1997 | Substantially Equivalent |
| K963381 | QUICKIE P300 SERIES | Apr 28, 1997 | Substantially Equivalent |
| K963385 | QUICKIE POWER WHEELCHAIRS P200 SERIES | Apr 28, 1997 | Substantially Equivalent |
| K924278 | QUICKIE P200 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K900330 | QUICKIE P300 WHEELCHAIR | Feb 15, 1990 | Substantially Equivalent |