| K-number | K251746 |
| Device name | Pure Impact |
| Applicant | Sofwave Medical, Ltd. |
| Product code | NGX |
| Device class | Class II |
| Decision date | Jul 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5850 |
The Pure Impact is an electrical muscle stimulation device intended for improving abdominal tone and strengthening muscles in the arms, thighs, and buttocks. It is designed for use by health professionals in aesthetic clinics and medical spas to stimulate healthy muscles for muscle training and performance improvement, not for treating medical diseases.
The Pure Impact is a standalone device modification of the predicate's Pure Impact Module, with the primary change being replacement of the SofWave main console control with an all-in-one PC featuring independent software and GUI. The wireless stimulation modules, electrode pads, and charging station remain unchanged. All stimulation parameters, energy delivery, treatment protocols, and electrical specifications are identical to the predicate.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10 for electrical safety and electromagnetic compatibility; ISO 14971 for risk management. The device incorporates software verification and validation testing and cybersecurity testing.
The subject device has identical intended use, indications, product code (NGX), classification, and regulatory requirements as the predicate. Waveform specifications, output channels, stimulation parameters, energy levels, and safety features are identical. The only modifications are the control interface and software architecture, which do not affect treatment delivery, mechanism of function, or energy specifications. Verification testing confirms the device performs safely and effectively identically to the predicate.
View the full FDA submission: accessdata.fda.gov