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Power Wheelchair Conversion Kit

by Alber Technologies, Inc.

510(k) K943789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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)SN Traditional NumberK943789 Date8 Nov 1994DecidedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0804-05 FDA Unclassified (pre-2012) initiated 1 Aug 2004
    • Terminated Z-0803-05 FDA Unclassified (pre-2012) initiated 1 Aug 2004

    may short circuit within the interface due to long term exposure of liquid

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  • Withdrawn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
SN

Overview

AI-generated summary, 1 Oct 2026

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

The Power Wheelchair Conversion Kit is a device designed to convert manual wheelchairs into powered wheelchairs. It is classified as a wheelchair, powered device in the medical specialty of Physical Medicine.

This device is supplied as a conversion kit and is subject to FDA 510(k) clearance with the K number K943789. It is classified as a Class 2 medical device under regulation 890.3860 and was determined to be substantially equivalent for some indications.

Other devices from Alber Technologies, Inc.

  • Scalamobil

    Class II

Questions

AI-generated answers, 1 Oct 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 Power Wheelchair Conversion Kit used for?

    The Power Wheelchair Conversion Kit is designed to convert manual wheelchairs into powered wheelchairs, providing users with enhanced mobility options. It is classified as a wheelchair, powered device in the medical specialty of Physical Medicine.

  • How is the Power Wheelchair Conversion Kit supplied?

    The device is supplied as a conversion kit, which includes all necessary components to transform a manual wheelchair into a powered one. It is not supplied as a complete wheelchair but rather as an add-on system for existing manual wheelchairs.

  • What is the regulatory status of the Power Wheelchair Conversion Kit?

    The Power Wheelchair Conversion Kit is subject to FDA 510(k) clearance with the K number K943789. It is classified as a Class 2 medical device under regulation 890.3860 and was determined to be substantially equivalent for some indications.

  • Is the Power Wheelchair Conversion Kit reusable or single-use?

    The device is supplied as a conversion kit that can be installed on a manual wheelchair to convert it to powered operation. While the kit itself is designed for installation on a wheelchair, the reusability would depend on the specific components and the manufacturer's instructions, which are not specified in the provided data.