Many microcurrent, EMS and RF devices are controlled by a phone App. The App cannot be treated as a mere remote control when it participates in energy output, defines use or controls safety.
1. Core App functions
- Select or combine output programs.
- Change current, frequency, waveform, time or level.
- Recommend programs from a questionnaire.
- Unlock hidden energy modes.
- Control temperature, contact detection or automatic stop.
- Display treatment or care plans and results.
2. Why software affects assessment
Classification looks at how the product achieves its intended purpose. If the App determines output and use, the App and hardware together form the device. The same housing with a new muscle-training, pain-management or higher-energy program may be a changed product.
3. What to provide
Provide software functions, version, program-to-parameter mapping, communications, abnormal states and update mechanism. Screenshots, videos and proposed instructions should match the actual App. For imported products, compare the China-region App with the overseas version and check whether accounts or data settings change available functions.
4. Common version risks
Examples include filing with a test App and later adding levels remotely, different regional accounts showing different purposes, or distributors using engineering mode to unlock programs. These actions break the assessed product boundary.
5. Software change control
- Record every version and parameter difference.
- Review by R&D, regulatory and marketing.
- Assess output, purpose and warning impact.
- Repeat tests or classification where necessary.
- Retain historical versions and release records.
Software is part of the product system when it controls function. Whether it creates medical software issues or changes overall classification requires product-specific review.