FDA 510(k)

APEX Manual Wheelchair

K-Number: K161425 · 2016-12-05

Decision Date2016-12-05

Product CodeIOR

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

APEX Manual Wheelchair is a medical device manufactured by Motion Composites. It received FDA 510(k) clearance on 2016-12-05 under approval number K161425. 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 APEX Manual Wheelchair?

APEX Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Motion Composites. The 510(k) number is K161425.

When was APEX Manual Wheelchair approved by the FDA?

APEX Manual Wheelchair received FDA 510(k) clearance on 2016-12-05, under approval number K161425.

What company makes APEX Manual Wheelchair?

APEX Manual Wheelchair is manufactured by Motion Composites.

What is the FDA product code for APEX Manual Wheelchair?

The FDA product code for APEX Manual Wheelchair is IOR.

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Related Devices (Code: IOR)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S K152021Pure TiltProactive Comfort, LLC

Official Source

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