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FDA 510(k)

Manual Wheelchair (W47)

K-Number: K252828 · 2025-12-05

ApplicantJiangsu Jumao X-Care Medical Equipment Co., , Ltd.
Decision Date2025-12-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (W47) is a medical device manufactured by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.. It received FDA 510(k) clearance on 2025-12-05 under approval number K252828. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Manual Wheelchair (W47)?

Manual Wheelchair (W47) is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.. The 510(k) number is K252828.

When was Manual Wheelchair (W47) approved by the FDA?

Manual Wheelchair (W47) received FDA 510(k) clearance on 2025-12-05, under approval number K252828.

What company makes Manual Wheelchair (W47)?

Manual Wheelchair (W47) is manufactured by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd..

What is the FDA product code for Manual Wheelchair (W47)?

The FDA product code for Manual Wheelchair (W47) is IOR.

Related Clinical Trials

NCT05776030 Multi-speed Ergonomic Wheelchair RECRUITING NCT04668326 Mobile Manual Standing Wheelchair for SCI COMPLETED

Other Devices by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

K252825Manual Wheelchair (W45) K253632Manual Wheelchair (W50)

Related Devices (Code: IOR)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K161425APEX Manual WheelchairMotion Composites K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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