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FDA 510(k)

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

K-Number: K163125 · 2017-04-10

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

Device Summary

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is a medical device manufactured by Firstkind Limited. It received FDA 510(k) clearance on 2017-04-10 under approval 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. It is manufactured by Firstkind Limited. The 510(k) number is K163125.

When was geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators approved by the FDA?

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

What company makes geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators?

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is manufactured by Firstkind Limited.

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.

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Official Source

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