510(k) Report

FDA applicant

Firstkind Limited

High Wycombe, GB12 decisions2014–20220 recalls

FDA records 12 decisions for Firstkind Limited (High Wycombe, GB) from 2014 to 2022: 12 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Firstkind, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Firstkind Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 22015: 12016: 12017: 12018: 22019: 12020: 22021: 12022: 1
2014high 2 (2014) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Firstkind Limited by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IPFStimulator, Muscle, Powered10decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning2decisions

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 64 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 7 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 10 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180082geko T-2 and geko Plus R-2Firstkind, Ltd. · 20183cite it
  • K152677geko T-2 Neuromuscular StimulatorFirstkind Limited · 20152cite it
  • K133638GEKOFirstkind Limited · 20141cites it
  • K181059geko T-3 Neuromuscular StimulatorFirstkind Limited · 20181cites it
  • K134001FireflyFirstkind Limited · 20141cites it
  • K160299geko (TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited · 20161cites it

What has FDA decided for it lately?

  • K220327geko W-3Firstkind Limited · 2022
  • K212762geko W-2Firstkind Limited · 2021
  • K201131firefly T-2Firstkind Limited · 2020
  • K193045geko™ W-2Firstkind Limited · 2020
  • K191113geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited · 2019
  • K181059geko T-3 Neuromuscular StimulatorFirstkind Limited · 2018
  • K180082geko T-2 and geko Plus R-2Firstkind, Ltd. · 2018
  • K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited · 2017

All 11 as Firstkind Limited →The one decision as Firstkind, Ltd. →