FDA 510(k)

NIO+ Adult

K-Number: K211968 · 2021-07-22

Decision Date2021-07-22

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIO+ Adult is a medical device manufactured by Waismed, Ltd.. It received FDA 510(k) clearance on 2021-07-22 under approval number K211968. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIO+ Adult?

NIO+ Adult is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Waismed, Ltd.. The 510(k) number is K211968.

When was NIO+ Adult approved by the FDA?

NIO+ Adult received FDA 510(k) clearance on 2021-07-22, under approval number K211968.

What company makes NIO+ Adult?

NIO+ Adult is manufactured by Waismed, Ltd..

What is the FDA product code for NIO+ Adult?

The FDA product code for NIO+ Adult is FMI.

Other Devices by Waismed, Ltd.

K160805NIO-P K190538NIO-I

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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.