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510(k) K252893

ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) by Aneuvo — Product Code SDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2026
Date Received
September 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class
Class II
Regulation Number
890.5851
Review Panel
PM
Submission Type

A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.

Other clearances for product code SDO

  • K251821 — ARC-EX System (November 14, 2025)
  • DEN240014 — ARC-EX System (December 19, 2024)