510(k) Report

FDA applicant

Scion Neurostim, LLC

Raleigh, NC1 decision2018–20180 recalls

FDA records 1 decision for Scion Neurostim, LLC (Raleigh, NC) in 2018: 1 De Novo grant. All are in product code QAR (Thermal Vestibular Stimulator For Headache). No 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 Scion Neurostim, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Scion Neurostim, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Scion”

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