FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIPPY
K Number: K983808
·
Decision Oct 14, 1999
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
6
Review Days
351
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Basic Information
- Device Name
- ZIPPY
- K Number
- K983808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pillar Technology, Inc.
- Date Received
- October 28, 1998
- Decision Date
- October 14, 1999
- 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 Pillar Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012846 | ZIPPY, MODEL I88WA | Nov 20, 2001 | Substantially Equivalent |
| K994127 | GLORY | Feb 3, 2000 | Substantially Equivalent |
| K972851 | ZIPPY | Jan 8, 1998 | Substantially Equivalent |
| K961888 | PILLAR 4-WHEEL SCOOTER | Oct 23, 1996 | Substantially Equivalent |
| K910265 | TRAVELER, MOTORIZED THREE-WHEELED VEHICLE | Feb 14, 1991 | Substantially Equivalent |