OCO

Mouthguard, Migraine/Tension Headache

产品代码: OCO
器械名称: Mouthguard, Migraine/Tension Headache
管理类别: 第 U 类（Unclassified）
FDA 专业组: Unknown
上市路径: 需提交 510(k) 上市前通告
该代码近三年的 510(k): 3 件

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： OCO

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。