Product Classification

Why Microcurrent Device Classification Cannot Be Based on Current Level Alone

Regulatory boundary analysis for microcurrent devices.

“微小电流”不是分类结论

微电流设备可能用于皮肤护理、健康调理、神经肌肉刺激、康复或疼痛相关场景。仅凭电流数值较小,不能排除医疗器械管理属性。

需要共同分析的因素

  • 电流、电压、波形、频率、脉宽和极性
  • 电极材质、面积、放置位置与接触介质
  • 程序、软件或 App 的控制逻辑
  • 目标人群、作用部位、使用时间和频率
  • 说明书和市场宣传中的实际用途表达
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.
Digital Project PortalCompliance Center Submit Assessment