Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators

K-Number: K163125 · 2017-04-10

ApplicantFirstkind Limited
Decision Date2017-04-10
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163125. 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-2 and geko™ Plus R-2 Neuromuscular Stimulators?

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Firstkind Limited. The 510(k) number is K163125.

When did geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators receive FDA 510(k) clearance?

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163125.

Who is the listed applicant for geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators?

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-2 and geko™ Plus R-2 Neuromuscular Stimulators?

The FDA product code for geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators 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 StimulatorsK181059geko T-3 Neuromuscular Stimulator

View all 9 devices →

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.

↑