说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
监管定义 / Regulatory definition
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.
监管信息 / Regulatory information
FDA product code: OMW
Device class: 1
Regulation: 890.5710
Specialty: Physical Medicine
Implant flag: N
Life sustaining/supporting flag: N
使用说明核对
该条目描述监管产品类别，不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书，核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。
来源、版本与许可
- 资料类型
- FDA 器械监管分类（非厂家操作说明书）
- 版本
- 2026-10-08
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.