geko(TM) Plus R-2 Neuromuscular Stimulator

510(k) Number

K160299 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• geko W-2

  Class II

  FDA 510(k) K212762 Active Cleared 29 Nov 2021

• geko™ W-2

  Class II

  FDA 510(k) K193045 Active Cleared 18 Jan 2020

• geko T-3 Neuromuscular Stimulator

  Class II

  FDA 510(k) K181059 Active Cleared 23 May 2018

• geko T-2 and geko T-3 Neuromuscular Stimulators

  Class II

  FDA 510(k) K191113 Active Cleared 18 Sep 2019

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

  Class II

  FDA 510(k) K163125 Active Cleared 10 Apr 2017

• geko T-2 Neuromuscular Stimulator

  Class II

  FDA 510(k) K152677 Active Cleared 23 Oct 2015

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