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.

Summary

Aneuvo's record lists two ExaStim® Stimulation System versions (EXA-001 and EXA-011) and two ReCure® Electrode Pads (PAD-003 and PAD-013). They're filed under SDO, transcutaneous electrical spine stimulators to improve skeletal muscle strength and sensation.

Class II, 21 CFR 890.5851. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Aneuvo filed from Los Angeles, California. Review took 197 calendar days (September 11, 2025 to March 27, 2026).

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: Product 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 ↗

Recent devices under product code SDO

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Data sourced from openFDA. This site is unofficial and independent of the FDA.