FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLORY
K Number: K994127
·
Decision Feb 3, 2000
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
6
Review Days
58
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Basic Information
- Device Name
- GLORY
- K Number
- K994127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pillar Technology, Inc.
- Date Received
- December 7, 1999
- Decision Date
- February 3, 2000
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 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 |
| K983808 | ZIPPY | Oct 14, 1999 | 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 |