Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown