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Caddy

by Afikim Electric Vehicles

510(k) K041186

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 NumberK041186 Date9 Sep 2004ClearedStatusActive

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  • Withdrawn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
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The device is a powered wheelchair, classified as a Class II medical device under FDA regulation 890.3860. It is identified by the product code ITI and was determined to be substantially equivalent through a traditional 510(k) clearance process. The device falls under the medical specialty of Physical Medicine and was reviewed by the Physical Medicine advisory committee.

The Caddy scooter is a transportable and foldable scooter developed for use in and around the house and for trips, particularly for individuals with mobility problems. It is manufactured by Afikim Electric Vehicles and received FDA 510(k) clearance under K041186 on September 9, 2004. The device is supplied as a finished product intended for personal mobility assistance in non-clinical settings.

Other devices from Afikim Electric Vehicles (S.A.E. AFIKIM)

See all devices from Afikim Electric Vehicles (S.A.E. AFIKIM) →

Questions

AI-generated answers, 25 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 Caddy device used for?

    The Caddy is a powered wheelchair scooter designed for personal mobility assistance, intended for use in and around the house and for trips by individuals with mobility problems in non-clinical settings.

  • How is the Caddy supplied and is it reusable?

    The Caddy is supplied as a finished product and is intended for repeated personal use as a mobility aid, not as a single-use device, based on its description as a transportable and foldable scooter for ongoing assistance.

  • What regulatory pathway was used for the Caddy’s FDA clearance?

    The Caddy received FDA clearance through a traditional 510(k) submission (K041186), demonstrating substantial equivalence to a legally marketed predicate device under regulation 890.3860.