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FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 890.5851
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253638Spinex, Inc. · 510k2026-04-20
K252893Aneuvo · 510k2026-03-27
K251821Onward Medical, Inc. · 510k2025-11-14
DEN240014Onward Medical, Inc. · 510k2024-12-19

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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