ExaStim® Stimulation System (EXA-001) +3 more— 510(k) K252893

Name: FDA 510(k) clearance K252893
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Aneuvo

FDA 510(k) clearance K252893 for ExaStim® Stimulation System (EXA-001) +3 more, Substantially Equivalent on 2026-03-27. Applicant: Aneuvo. Device class: 2.

Clearance details

Device name as filed: ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
Applicant: Aneuvo
Product code: Code SDO
Device class: Class 2
Regulation: 21 CFR 890.5851
Advisory panel: Physical Medicine
Date received: 2025-09-11
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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