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C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580

by Warepalmy Enterprise, LLC (Usa)

510(k) K000356

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 NumberK000356 Date25 Aug 2000ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons. This device is classified as a Vehicle, Motorized 3-Wheeled under regulation number 890.3800 and product code INI.

The device received FDA 510(k) clearance K000356 on August 25, 2000, following a traditional review process. It is classified as Class II and falls under the medical specialty of Physical Medicine. The applicant is Warepalmy Enterprise, LLC (USA).

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