# Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
> **Product code: SDO** · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5851
## Classification
- **FDA Product Code:** SDO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 890.5851
- **Review panel:** PM
- **Medical specialty:** Physical Medicine
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SDO)
---
*AI Analytics · CC0 1.0*