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FDA 510(k)

RoughRider Aurora Manual Wheelchair

K-Number: K200715 · 2022-06-24

ApplicantRoughrider America, LLC
Decision Date2022-06-24
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RoughRider Aurora Manual Wheelchair is a medical device manufactured by Roughrider America, LLC. It received FDA 510(k) clearance on 2022-06-24 under approval number K200715. 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 RoughRider Aurora Manual Wheelchair?

RoughRider Aurora Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2022-06-24. It is manufactured by Roughrider America, LLC. The 510(k) number is K200715.

When was RoughRider Aurora Manual Wheelchair approved by the FDA?

RoughRider Aurora Manual Wheelchair received FDA 510(k) clearance on 2022-06-24, under approval number K200715.

What company makes RoughRider Aurora Manual Wheelchair?

RoughRider Aurora Manual Wheelchair is manufactured by Roughrider America, LLC.

What is the FDA product code for RoughRider Aurora Manual Wheelchair?

The FDA product code for RoughRider Aurora Manual Wheelchair is IOR.

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Related Devices (Code: IOR)

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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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