SDO — Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Class II

FDA Device Classification

Classification Details

Product Code
SDO
Device Class
Class II
Regulation Number
890.5851
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252893aneuvoExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReMarch 27, 2026
K251821onward medicalARC-EX SystemNovember 14, 2025
DEN240014onward medicalARC-EX SystemDecember 19, 2024