Computerized Behavioral Therapy Device For Migraine

SEE · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5806

Classification

FDA Product Code: SEE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5806
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.

Market data

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

Source

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