geko

Device Name

Neuromuscular Electro-stimulation Device

Model / Reference

T-3, T3RW02

Primary DI / UDI-DI

05060294770954

Basic UDI-DI

506029477T3QK

EMDN Code

N0199 Encephalic and peripheral nervous system devices - other

Device Class

Class IIa

Market of Registration

Netherlands

EUDAMED SRN

GB-MF-000010541

Authorised representative

Emergo Europe B.V. NL-AR-000000116

• geko

  Class IIa

  CE/MDR

• 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

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