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FDA 510(k)

geko W-2

K-Number: K212762 · 2021-11-29

ApplicantFirstkind Limited
Decision Date2021-11-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko W-2 is a medical device manufactured by Firstkind Limited. It received FDA 510(k) clearance on 2021-11-29 under approval number K212762. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the geko W-2?

geko W-2 is a medical device that received FDA 510(k) clearance on 2021-11-29. It is manufactured by Firstkind Limited. The 510(k) number is K212762.

When was geko W-2 approved by the FDA?

geko W-2 received FDA 510(k) clearance on 2021-11-29, under approval number K212762.

What company makes geko W-2?

geko W-2 is manufactured by Firstkind Limited.

What is the FDA product code for geko W-2?

The FDA product code for geko W-2 is IPF.

Other Devices by Firstkind Limited

K160299geko(TM) Plus R-2 Neuromuscular Stimulator K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators K181059geko T-3 Neuromuscular Stimulator K191113geko T-2 and geko T-3 Neuromuscular Stimulators K201131firefly T-2 K193045geko™ W-2

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Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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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