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FDA 510(k)

geko T-3 Neuromuscular Stimulator

K-Number: K181059 · 2018-05-23

ApplicantFirstkind Limited
Decision Date2018-05-23
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko T-3 Neuromuscular Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2018-05-23 under 510(k) number K181059. 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 T-3 Neuromuscular Stimulator?

geko T-3 Neuromuscular Stimulator is a medical device that received FDA 510(k) clearance on 2018-05-23. The listed applicant is Firstkind Limited. The 510(k) number is K181059.

When did geko T-3 Neuromuscular Stimulator receive FDA 510(k) clearance?

geko T-3 Neuromuscular Stimulator received FDA 510(k) clearance on 2018-05-23, under 510(k) number K181059.

Who is the listed applicant for geko T-3 Neuromuscular Stimulator?

The FDA 510(k) record lists Firstkind Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for geko T-3 Neuromuscular Stimulator?

The FDA product code for geko T-3 Neuromuscular Stimulator is IPF.

Other records listing Firstkind Limited 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.

K220327geko W-3K212762geko W-2K201131firefly T-2K193045geko™ W-2K191113geko T-2 and geko T-3 Neuromuscular StimulatorsK180082geko T-2 and geko Plus R-2

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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