SDO

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Product code

SDO

Device name

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Device class

Class 2

21 CFR

21 CFR 890.5851

Medical specialty

Physical Medicine

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-04-20.

2 summaries are archived here for direct download.