FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOOSTER LITE 3 MOTORIZED SCOOTER
K Number: K955274
·
Decision Nov 4, 1996
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
15
Review Days
355
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BOOSTER LITE 3 MOTORIZED SCOOTER
- K Number
- K955274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Optimed Technologies, Inc.
- Date Received
- November 15, 1995
- Decision Date
- November 4, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.
Virgo Mobility Scooter (Virgo-D,Virgo-F)
FDA 510(k)
FDA Class 2
·Physical Medicine
Scooter (YD-03)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (Air Carbon)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (X-12, X-14, X-17)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electrical Scooter (SM4226)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Mobility Scooter (MJMA01, MJMA02)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Optimed Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972520 | OPTIVIEW | Sep 29, 1997 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent |
| K921883 | ENDOSCOPE | Nov 23, 1992 | Substantially Equivalent |