SDO — Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Class II
FDA product code SDO covers "Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation", a Class II medical device regulated under 21 CFR 890.5851. Submissions are reviewed by the Physical Medicine panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SDO
- Device Class
- Class II
- Regulation Number
- 890.5851
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.