geko W-2— 510(k) K212762

Substantially Equivalent

Firstkind Limited

FDA 510(k) clearance K212762 for geko W-2, Substantially Equivalent on 2021-11-29. 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: 2021-08-31
Decision date: 2021-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: High Wycombe, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Firstkind Limited

K220327 — geko W-32022-03-04
K201131 — firefly T-22020-05-28
K193045 — geko W-22020-01-18
K191113 — geko T-2 and geko T-3 Neuromuscular Stimulators2019-09-18
K181059 — geko T-3 Neuromuscular Stimulator2018-05-23

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