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Power Wheelchair - D20

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242468

by Anhui Jbh Medical Apparatus Co., Ltd

Identifiers

510(k) Number
K242468 FDA 510(k)
FDA Product Code
ITI FDA 510(k)
Models / Variants
D10 FDA 510(k)
D12 FDA 510(k)
D15 FDA 510(k)
D17 FDA 510(k)
D20 FDA 510(k)
D37 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)

The Power Wheelchair (D10, D12, D15, D17, D20, D37) is a powered mobility device classified as a Wheelchair, Powered, designed to assist individuals with limited mobility. It features a foldable frame, seat, armrests, and an electrical system including brushless motors, electromagnetic brakes, a controller, and a rechargeable lithium-ion battery for rear-wheel drive propulsion.

This device is intended for use in clinical and home settings, providing mobility assistance to users. It is supplied as a reusable medical device, with specifications including foldable design for transport and storage. The device complies with FDA 510(k) clearance under regulation 890.3860, with a review panel classification under Physical Medicine. Multiple FEI registration numbers correspond to the various model variants.

Frequently asked questions

What settings can this power wheelchair be used in, and how does its design accommodate different environments?

This power wheelchair is designed for use in both clinical and home settings, providing mobility assistance to individuals with limited mobility. Its foldable frame, seat, and armrests allow for easy transport and storage, making it practical for environments where space or portability is a concern. The rear-wheel drive system with brushless motors and electromagnetic brakes ensures stable and efficient movement, suitable for indoor and outdoor use.

Is this power wheelchair intended for single-use or can it be reused? How does this affect maintenance?

This power wheelchair is classified as a reusable medical device. As such, it is not intended for single-use and is designed to be cleaned, maintained, and reused according to manufacturer guidelines. Proper maintenance, including battery care and mechanical checks, is essential to ensure safe and reliable operation over time.

What types of battery and propulsion system does this power wheelchair use, and how does it impact its performance?

The power wheelchair features a rechargeable lithium-ion battery for propulsion, paired with brushless motors and electromagnetic brakes. This combination provides efficient energy use, smooth operation, and reliable braking, enhancing both performance and user safety during mobility tasks.

How do I determine which model variant of this power wheelchair is best suited for my needs?

The power wheelchair comes in multiple model variants (D10, D12, D15, D17, D20, D37), each with distinct specifications and FEI registration numbers. While the exact differences between models aren’t detailed here, the foldable design and rear-wheel drive system are consistent across variants. Consulting with a healthcare provider or mobility specialist can help match your specific mobility requirements with the appropriate model.

What regulatory pathway was followed for this power wheelchair, and how does that affect its use?

This power wheelchair was cleared through the FDA’s 510(k) process under regulation 890.3860, with a review panel classification under Physical Medicine. The clearance type is traditional, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This regulatory pathway ensures compliance with U.S. safety and performance standards, but it does not define clinical indications—those are determined by healthcare professionals based on patient 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 (D10, D12, D15, D17, D20, D37), Power Wheelchair (D10, D12, D15, D17, D20, D37)… - FDA.report, K242468 FDA 510 (k) - Power Wheelchair (D10, Power Wheelchair - FDA Clearance | Medical Device Navigator

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) K242468 24 fields · synced Sep 19, 2026