Electrical Tongue Stimulator To Treat Motor Deficits

QCF · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5889

Classification

FDA Product Code: QCF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5889
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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