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FDA 510(k)

MyOn HC Manual Wheelchair

K-Number: K152536 · 2016-01-05

ApplicantInvacare Corporation
Decision Date2016-01-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MyOn HC Manual Wheelchair is a medical device manufactured by Invacare Corporation. It received FDA 510(k) clearance on 2016-01-05 under approval number K152536. 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 MyOn HC Manual Wheelchair?

MyOn HC Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-01-05. It is manufactured by Invacare Corporation. The 510(k) number is K152536.

When was MyOn HC Manual Wheelchair approved by the FDA?

MyOn HC Manual Wheelchair received FDA 510(k) clearance on 2016-01-05, under approval number K152536.

What company makes MyOn HC Manual Wheelchair?

MyOn HC Manual Wheelchair is manufactured by Invacare Corporation.

What is the FDA product code for MyOn HC Manual Wheelchair?

The FDA product code for MyOn HC Manual Wheelchair is IOR.

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Other Devices by Invacare Corporation

K162696Kuschall Advance Manual Wheelchair K162686Kuschall Champion Manual Wheelchair K162692Kuschall K-Series Attract Manual Wheelchair K160630Invacare Platinum Mobile Oxygen Concentrator K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

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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 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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