FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIPPIE 3 TS/SP WHEELCHAIR/STANDER
K Number: K920463
·
Decision Apr 2, 1992
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- ZIPPIE 3 TS/SP WHEELCHAIR/STANDER
- K Number
- K920463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunrise Medical Quickie Designs, Inc.
- Date Received
- January 27, 1992
- Decision Date
- April 2, 1992
- Product Code
- IPL
- 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 |
|---|---|---|---|
| IPL | Wheelchair, Standup | FDA class 2 | Physical Medicine |
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