SDOClass II
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Physical Medicine · 21 CFR 890.5851
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.
MDR events1All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances4All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Spinex, Inc.Apr 20, 2026
K253638 · xStep (xStep)
- AneuvoMar 27, 2026
K252893 · ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
- Onward Medical, Inc.Nov 14, 2025
K251821 · ARC-EX System
- Onward Medical, Inc.Dec 19, 2024
DEN240014 · ARC-EX System