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Booster Lite 4 Motorized Scooter

by Optimed Technologies, Inc.

510(k) K955276

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955276 Date4 Nov 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Optimed Technologies, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.