510(k) Report

FDA applicant

Myolyn, LLC

Gainesville, FL2 decisions2017–20221 recall

FDA records 2 decisions for Myolyn, LLC (Gainesville, FL) from 2017 to 2022: 2 510(k) clearances. All are in product code GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2022

2017: 12022: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2017high 1 (2022) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Myolyn, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZIStimulator, Neuromuscular, External Functional2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 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.

  • K170132MyoCycle Home, MyoCycle ProMyolyn, LLC · 20171cites it

What has FDA decided for it lately?

  • K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC · 20221 recall
  • K170132MyoCycle Home, MyoCycle ProMyolyn, LLC · 2017

All 2 as Myolyn, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K213925Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.Jul 19, 2022Class II