510(k) K955276
K955276 is an FDA 510(k) premarket notification submitted by Optimed Technologies, Inc. for the device "BOOSTER LITE 4 MOTORIZED SCOOTER". The FDA issued a decision of Substantially Equivalent on November 4, 1996. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Optimed Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1996
- Date Received
- November 15, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vehicle, Motorized 3-Wheeled
- Device Class
- Class II
- Regulation Number
- 890.3800
- Review Panel
- PM
- Submission Type