K252893

ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

510(k) number
K252893
Device name
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
Applicant
Aneuvo CA · US
Product code
SDO — Transcutaneous Electrical Spine Stimulator To Improv
Decision date
2026-03-27
Date received
2025-09-11
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K252893.pdf

Official FDA record: K252893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.