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FDA 510(k)

Rowheels Revolution 1.0

K-Number: K190699 · 2019-05-09

ApplicantRowheels, Inc.
Decision Date2019-05-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Rowheels Revolution 1.0 is a medical device manufactured by Rowheels, Inc.. It received FDA 510(k) clearance on 2019-05-09 under approval number K190699. 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 Rowheels Revolution 1.0?

Rowheels Revolution 1.0 is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by Rowheels, Inc.. The 510(k) number is K190699.

When was Rowheels Revolution 1.0 approved by the FDA?

Rowheels Revolution 1.0 received FDA 510(k) clearance on 2019-05-09, under approval number K190699.

What company makes Rowheels Revolution 1.0?

Rowheels Revolution 1.0 is manufactured by Rowheels, Inc..

What is the FDA product code for Rowheels Revolution 1.0?

The FDA product code for Rowheels Revolution 1.0 is IOR.

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Official Source

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