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C2000 Powered Wheelchair

by Otto Bock HealthCare LP

510(k) K101524

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 NumberK101524 Date29 Sep 2010ClearedStatusActive

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  • Withdrawn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 C2000 Powered Wheelchair is a motorised mobility device designed for individuals requiring powered assistance. It falls under the classification of a powered wheelchair, providing enhanced mobility for users with limited ambulatory capacity, often due to physical disabilities or neurological conditions.

This device is intended for use in both indoor and outdoor environments, offering adjustable features such as armrest height and depth, protective clothing support, and full lighting. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K101524) and falls under Class II (Device Class 2) with a regulation number of 890.3860. It is not single-use and does not require sterile conditions. The wheelchair may be customised with optional controls, including parallel swing control and speed adjustments, to meet individual user needs.

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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 C2000 Powered Wheelchair designed to be used in?

    The C2000 Powered Wheelchair is specifically designed for use in both indoor and outdoor settings. Its construction and features, such as adjustable armrests and full lighting, make it suitable for a variety of environments where enhanced mobility is required.

  • Is the C2000 Powered Wheelchair intended for single-use or can it be reused?

    The C2000 Powered Wheelchair is a reusable medical device. It is not designed for single-use and does not require sterile conditions, making it suitable for long-term use by individuals requiring powered mobility assistance.

  • What customization options are available for the C2000 Powered Wheelchair to meet individual user needs?

    The C2000 Powered Wheelchair can be customized with optional controls, including parallel swing control and speed adjustments. These features allow for tailored adjustments to better suit the specific mobility requirements and preferences of the user.

  • How is the C2000 Powered Wheelchair regulated in the United States?

    The C2000 Powered Wheelchair is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K101524. It falls under Class II (Device Class 2) and is categorized under regulation number 890.3860, indicating it has been determined to be substantially equivalent to a legally marketed device.

  • What are the key adjustable features of the C2000 Powered Wheelchair?

    The C2000 Powered Wheelchair includes adjustable features such as armrest height and depth, as well as protective clothing support. These adjustments help accommodate the user’s physical needs and ensure comfort during use.