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FDA 510(k)

Bowhead ERA Wheelchairs

K-Number: K243111 · 2025-01-10

ApplicantBowhead Design Corp.
Decision Date2025-01-10
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Bowhead ERA Wheelchairs is a medical device manufactured by Bowhead Design Corp.. It received FDA 510(k) clearance on 2025-01-10 under approval number K243111. 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 Bowhead ERA Wheelchairs?

Bowhead ERA Wheelchairs is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Bowhead Design Corp.. The 510(k) number is K243111.

When was Bowhead ERA Wheelchairs approved by the FDA?

Bowhead ERA Wheelchairs received FDA 510(k) clearance on 2025-01-10, under approval number K243111.

What company makes Bowhead ERA Wheelchairs?

Bowhead ERA Wheelchairs is manufactured by Bowhead Design Corp..

What is the FDA product code for Bowhead ERA Wheelchairs?

The FDA product code for Bowhead ERA Wheelchairs is IOR.

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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