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FDA 510(k)

Manual Wheelchair (SYIV100A008)

K-Number: K252517 · 2025-10-03

ApplicantNingbo Shenyu Medical Equipment Co.,Ltd
Decision Date2025-10-03
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (SYIV100A008) is a medical device manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2025-10-03 under approval number K252517. 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 (SYIV100A008)?

Manual Wheelchair (SYIV100A008) is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd. The 510(k) number is K252517.

When was Manual Wheelchair (SYIV100A008) approved by the FDA?

Manual Wheelchair (SYIV100A008) received FDA 510(k) clearance on 2025-10-03, under approval number K252517.

What company makes Manual Wheelchair (SYIV100A008)?

Manual Wheelchair (SYIV100A008) is manufactured by Ningbo Shenyu Medical Equipment Co.,Ltd.

What is the FDA product code for Manual Wheelchair (SYIV100A008)?

The FDA product code for Manual Wheelchair (SYIV100A008) is IOR.

Related Clinical Trials

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

Other Devices by Ningbo Shenyu Medical Equipment Co.,Ltd

K201461Manual Wheelchair, Model A011 K231110Manual Wheelchair (A006) K253599Electric Wheelchair (W-A807, W-A807L)

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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