NRW

Stimulator, Intramuscular, Automatic

产品代码

NRW

器械名称

Stimulator, Intramuscular, Automatic

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.5580

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The Automatic Intramuscular Stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter. The motor unit has a mounted disposal syringe and a needle mounting hardware for a disposable needle, and enables the practitioner to administer treatment with less physical effort. An EMG needle is used instead of an acupuncture needle because it is less flexible than the acupuncture needle

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）。