Technical and Regulatory Challenges
“Microcurrent” is not automatically a non-medical technology category. Whether the product stimulates nerves or muscles, involves pain, rehabilitation, treatment or pathological conditions, and how current parameters relate to the treatment area all affect pathway assessment.
Typical Information Required
- Current, voltage, frequency, pulse width and waveform
- Electrode material, area, number and body-contact method
- Control software, levels, treatment duration and abnormal-condition protection
- Use in healthy populations, comfort and safety verification