Booster Lite 4 Motorized Scooter
510(k) K955276
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955276 | Date4 Nov 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
This device is a motorized three-wheeled vehicle classified under the Physical Medicine specialty. It is identified as the BOOSTER LITE 4 MOTORIZED SCOOTER with model reference K955276.
It received FDA 510(k) clearance as a substantially equivalent device on November 4, 1996, under product code INI and regulation number 890.3800. The device is manufactured by Optimed Technologies, Inc. and is registered in the FDA database with multiple associated FEI and registration numbers.
Other devices from Optimed Technologies, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the BOOSTER LITE 4 MOTORIZED SCOOTER used for?
The BOOSTER LITE 4 MOTORIZED SCOOTER is a motorized three-wheeled vehicle classified under the Physical Medicine specialty, designed to assist with mobility in clinical or rehabilitative settings as indicated by its FDA 510(k) clearance and product code INI under regulation 890.3800.
How is the BOOSTER LITE 4 MOTORIZED SCOOTER supplied or identified?
The device is supplied as a specific model identified by the reference K955276 and is manufactured by Optimed Technologies, Inc. It is registered in the FDA database with multiple FEI and registration numbers associated with its clearance and distribution.
Is the BOOSTER LITE 4 MOTORIZED SCOOTER reusable or single-use?
As a motorized three-wheeled vehicle, the BOOSTER LITE 4 MOTORIZED SCOOTER is designed for repeated use over time and is not a single-use device; its construction and intended function support durable, reusable operation in mobility assistance applications.