NYZ
- 产品代码
- NYZ
- 器械名称
- Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.5850
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
FDA 分类定义
Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.
FDA 官方分类页： NYZ
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。