geko(TM) Plus R-2 Neuromuscular Stimulator— 510(k) K160299

Name: FDA 510(k) clearance K160299
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Substantially Equivalent

Firstkind Limited

FDA 510(k) clearance K160299 for geko(TM) Plus R-2 Neuromuscular Stimulator, Substantially Equivalent on 2016-04-08. 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: 2016-02-04
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Special
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.