Decision Date2021-07-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NIO+ Adult is the device name listed in this FDA 510(k) record. The listed applicant is Waismed, Ltd.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) 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. The listed applicant is Waismed, Ltd.. The 510(k) number is K211968.
When did NIO+ Adult receive FDA 510(k) clearance?
NIO+ Adult received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211968.
Who is the listed applicant for NIO+ Adult?
The FDA 510(k) record lists Waismed, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NIO+ Adult?
The FDA product code for NIO+ Adult is FMI.
Other records listing Waismed, Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.