FDA applicant

Eneura Therapeutics, LLC

Orono, MN2 decisions2013–20140 recalls

FDA records 2 decisions for Eneura Therapeutics, LLC (Orono, MN) from 2013 to 2014: 1 510(k) clearance and 1 De Novo grant. All are in product code OKP (Transcranial Magnetic Stimulator For The…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eneura Therapeutics”.

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 Eneura Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Eneura Therapeutics, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Eneura”

FDA records each applicant name separately; these may or may not be the same firm.

Eneura, Inc. 4

Eneura Therapeutics, LLC

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Eneura”