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Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

FDA product code SDO · 3 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.5851
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-11-14 – 2026-04-20

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.

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