Shenzhen Qianyu Technology Co., Ltd. · Class II · Cleared Oct 17, 2025
| K-number | K250227 |
| Device name | JOVS Electric Stimulation Beauty Device (JE2) |
| Applicant | Shenzhen Qianyu Technology Co., Ltd. |
| Product code | NFO |
| Device class | Class II |
| Decision date | Oct 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
The JOVS Electric Stimulation Beauty Device (JE2) is a portable, rechargeable, over-the-counter aesthetic device with a spring electrode head designed for facial and neck skin stimulation. It consists of a main unit, charging base, and power cable, powered by an internal lithium battery.
The device uses pulsed biphasic square wave electrical stimulation at 2.5 kHz frequency with regulated voltage output. Key differences from predicates include a lithium battery power source (versus alkaline or mains), two output modes (versus one to four), maximum output voltage of 27V–36.7V at various impedances, and dimensions of 202×33×66mm weighing 634g.
ISO 10993-5, 10993-10, and 10993-23 for biocompatibility; IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10 for electrical safety; IEC 62133-2 for lithium battery safety; and FDA guidance for powered muscle stimulator waveform parameters.
The device has the same intended use (over-the-counter aesthetic facial and neck stimulation) as predicate devices and employs identical fundamental electrical stimulation technology. Minor differences in power source, output modes, waveform parameters, and materials do not raise safety or effectiveness concerns because all output parameters are within ranges of predicate devices and the device passes applicable electrical safety and biocompatibility standards.
View the full FDA submission: accessdata.fda.gov