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FDA 510(k)

NIO+ Adult

K-Number: K211968 · 2021-07-22

ApplicantWaismed, Ltd.
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.

Related Clinical Trials

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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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.

K190538NIO-IK160805NIO-PK062940BONE INJECTION GUN (B.I.G.)K022415BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1STK981853BONE INJECTION GUN (B.I.G.) DEVICE

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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.

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