Mouthguard, Migraine/Tension Headache

OCO · Unclassified · Unknown

Classification

FDA Product Code: OCO
Device class: Unclassified
Regulation: —
Review panel: DE
Medical specialty: Unknown
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 10

Source

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