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FDA 510(k)

Manual Wheelchair (HM305-Air1, HM305-Air2)

K-Number: K252687 · 2025-11-21

ApplicantSuzhou Master Machinery Manufacturing Co.,Ltd
Decision Date2025-11-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (HM305-Air1, HM305-Air2) is a medical device manufactured by Suzhou Master Machinery Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2025-11-21 under approval number K252687. 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 (HM305-Air1, HM305-Air2)?

Manual Wheelchair (HM305-Air1, HM305-Air2) is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Suzhou Master Machinery Manufacturing Co.,Ltd. The 510(k) number is K252687.

When was Manual Wheelchair (HM305-Air1, HM305-Air2) approved by the FDA?

Manual Wheelchair (HM305-Air1, HM305-Air2) received FDA 510(k) clearance on 2025-11-21, under approval number K252687.

What company makes Manual Wheelchair (HM305-Air1, HM305-Air2)?

Manual Wheelchair (HM305-Air1, HM305-Air2) is manufactured by Suzhou Master Machinery Manufacturing Co.,Ltd.

What is the FDA product code for Manual Wheelchair (HM305-Air1, HM305-Air2)?

The FDA product code for Manual Wheelchair (HM305-Air1, HM305-Air2) is IOR.

Related Clinical Trials

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

Other Devices by Suzhou Master Machinery Manufacturing Co.,Ltd

K222711HS186B Scooter K241463Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) K251638Mobility Scooter (MS160C) K242982Mobility Scooter (MS160A) K253870Electric Wheelchair (MP148)

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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