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FDA 510(k)

geko(TM) Plus R-2 Neuromuscular Stimulator

K-Number: K160299 · 2016-04-08

ApplicantFirstkind Limited
Decision Date2016-04-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko(TM) Plus R-2 Neuromuscular Stimulator is a medical device manufactured by Firstkind Limited. It received FDA 510(k) clearance on 2016-04-08 under approval number K160299. 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(TM) Plus R-2 Neuromuscular Stimulator?

geko(TM) Plus R-2 Neuromuscular Stimulator is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Firstkind Limited. The 510(k) number is K160299.

When was geko(TM) Plus R-2 Neuromuscular Stimulator approved by the FDA?

geko(TM) Plus R-2 Neuromuscular Stimulator received FDA 510(k) clearance on 2016-04-08, under approval number K160299.

What company makes geko(TM) Plus R-2 Neuromuscular Stimulator?

geko(TM) Plus R-2 Neuromuscular Stimulator is manufactured by Firstkind Limited.

What is the FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator?

The FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator is IPF.

Related Clinical Trials

NCT06811545 Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy NOT_YET_RECRUITING

Other Devices by Firstkind Limited

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 K212762geko W-2

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Related Devices (Code: IPF)

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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.

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