QUG

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

产品代码: QUG
器械名称: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 874.3305
FDA 专业组: Ear, Nose, Throat
上市路径: 豁免 510(k)（仍须遵守通用控制与注册列名）

FDA 分类定义

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.

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： QUG

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。