FDA product code SDO

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Physical Medicine·Class 2·21 CFR 890.5851
US regulatory classifications
US Product Code (FDA)
SDO
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 890.5851
View CFR Regulation →
Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.