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Power Wheelchair - D22

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242448

by Anhui Jbh Medical Apparatus Co., Ltd

Identifiers

510(k) Number
K242448 FDA 510(k)
FDA Product Code
ITI FDA 510(k)
Models / Variants
D03 FDA 510(k)
D05 FDA 510(k)
D06 FDA 510(k)
D09 FDA 510(k)
D11 FDA 510(k)
D16 FDA 510(k)
D22 FDA 510(k)
D23 FDA 510(k)
D26 FDA 510(k)
D36 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Wheelchair, Powered, as classified under FDA regulation 890.3860. It is an electrically powered mobility aid designed to assist individuals with limited mobility in independent movement. The wheelchair features a two-wheel drive system and is equipped to respond to user commands via joystick or Bluetooth Low Energy (BLE) remote control, enabling customised operation for enhanced accessibility.

The Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) is supplied as a foldable, battery-operated device intended for home or clinical use. It has received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II medical device, and is authorised for distribution in the United States. No specific sterility or single-use requirements are noted; however, standard maintenance guidelines apply to ensure safe and reliable operation.

Frequently asked questions

How is this power wheelchair controlled, and what environments is it designed for use in?

This power wheelchair is operated via a joystick or a Bluetooth Low Energy (BLE) remote control, allowing customizable control for enhanced accessibility. It is designed for both home and clinical use, making it versatile for indoor and controlled outdoor environments where mobility assistance is needed.

Is this wheelchair foldable, and how does that affect its portability?

Yes, this power wheelchair is supplied as a foldable design, which improves its portability. This feature makes it easier to store in tight spaces, transport, and maneuver in environments where space may be limited, such as homes or clinical settings.

What type of maintenance does this wheelchair require, and is it intended for single-use or reuse?

The wheelchair is not intended for single-use; instead, it requires standard maintenance guidelines to ensure safe and reliable operation. Since it is battery-operated and designed for repeated use, regular upkeep—such as battery checks, mechanical inspections, and cleaning—will be necessary to maintain functionality.

Is this device approved for use in the United States, and what regulatory pathway was followed?

Yes, this power wheelchair has received FDA 510(k) clearance under the Traditional review pathway, classifying it as a Class II medical device. This means it has been evaluated and authorized for distribution in the United States following FDA guidelines.

Does this wheelchair come with multiple models or sizes, and how would I determine which one fits my needs?

The device is listed under multiple product codes (D03, D05, D06, etc.), which may correspond to different models or configurations. While the exact specifications for each model aren’t detailed here, the manufacturer likely offers variations to accommodate different user requirements such as weight capacity, seat dimensions, or drive systems. Consulting the manufacturer’s documentation or a healthcare professional would help determine the best fit for your specific needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36 ..., Power Wheelchair (D03, D05, D06, D09, D11, D16, D22… - FDA.report, K242448 FDA 510 (k) - Power Wheelchair (D03, PDF Ivy Wang Technical Manager Room 1 401, Dongfang Building, 1500# Century ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anhui Jbh Medical Apparatus Co., Ltd
FDA Applicant
Anhui Jbh Medical Apparatus Co., Ltd.

Sources (1)

  • FDA 510(k) K242448 24 fields · synced Sep 20, 2026