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Powered Wheelchair Model B-500

by Otto Bock HealthCare LP

510(k) K041208

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 NumberK041208 Date1 Oct 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  • Withdrawn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, 18 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 Powered Wheelchair Model B-500 is a motorised mobility device designed for individuals requiring electric propulsion. It falls under the classification of a powered wheelchair, providing independent mobility for users with limited physical capacity to operate manual wheelchairs.

This device is intended for use in clinical and home settings, supplied as a reusable medical aid. It is not sterile and is regulated under FDA 510(k) clearance (K041208) as a Class II device. Multiple model variants are listed under registration numbers, including 9615350 and 9615410, with regulatory compliance under 890.3860. No MRI safety or single-use specifications are indicated.

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Questions

AI-generated answers, 18 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 types of environments is the Powered Wheelchair Model B-500 intended for use in?

    The Powered Wheelchair Model B-500 is designed for use in both clinical settings, such as hospitals or rehabilitation centers, and home environments. It is specifically intended to provide electric propulsion for individuals who require mobility assistance but have limited capacity to operate manual wheelchairs.

  • Is the Powered Wheelchair Model B-500 a single-use or reusable device?

    The Powered Wheelchair Model B-500 is supplied as a reusable medical aid. It is not intended for single-use and is meant to be used repeatedly by authorized users in clinical or home settings.

  • What regulatory pathway does the Powered Wheelchair Model B-500 follow, and what does that mean for its use?

    The Powered Wheelchair Model B-500 follows the FDA 510(k) clearance pathway, classified as a Class II device under the regulatory code 890.3860. This means it has been determined to be substantially equivalent to a legally marketed device and is approved for use in the United States under these regulatory guidelines.

  • Are there multiple model variants of the Powered Wheelchair Model B-500, and how can I identify them?

    Yes, there are multiple model variants of the Powered Wheelchair Model B-500, each associated with specific registration numbers such as 9615350 and 9615410. These variants are listed under various FEI numbers in the FDA database, so you can identify them by checking the registration or FEI numbers provided by the manufacturer or in documentation.

  • Is the Powered Wheelchair Model B-500 sterile, and how should it be handled?

    The Powered Wheelchair Model B-500 is not sterile. Since it is a reusable device, it should be cleaned and maintained according to manufacturer guidelines to ensure hygiene and safe use. Proper handling and care are essential to prevent contamination and ensure longevity.