FDA applicant

Eneura, Inc.

Sunnyvale, CA4 decisions2016–20230 recalls

FDA records 4 decisions for Eneura, Inc. (Sunnyvale, CA) from 2016 to 2023: 4 510(k) clearances. All are in product code OKP (Transcranial Magnetic Stimulator For The…). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eneura®, Inc.”.

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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Eneura, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eneura, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Eneura”

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

Eneura Therapeutics, LLC 2

Eneura, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Eneura”