OMW
- 产品代码
- OMW
- 器械名称
- Adhesive Backed Thermal Skin Patches
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 890.5710
- FDA 专业组
- Physical Medicine
- 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
Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns.
FDA 官方分类页： OMW
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。