geko T-2 and geko Plus R-2 Neuromuscular Stimulators— 510(k) K163125

Name: FDA 510(k) clearance K163125
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Substantially Equivalent

Firstkind Limited

FDA 510(k) clearance K163125 for geko T-2 and geko Plus R-2 Neuromuscular Stimulators, Substantially Equivalent on 2017-04-10. Applicant: Firstkind Limited. Device class: 2.

Clearance details

Applicant: Firstkind Limited
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2016-11-08
Decision date: 2017-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: High Wycombe, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.