geko T-2 and geko T-3 Neuromuscular Stimulators— 510(k) K191113

Name: FDA 510(k) clearance K191113
Creator: U.S. Food and Drug Administration
Published: 2019-09-18

Substantially Equivalent

Firstkind Limited

FDA 510(k) clearance K191113 for geko T-2 and geko T-3 Neuromuscular Stimulators, Substantially Equivalent on 2019-09-18. 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: 2019-04-26
Decision date: 2019-09-18
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.