DEVICE DETAILS
| NAME OF DEVICE | MAGNETO THERAPY |
|---|---|
| ESTABLISHMENT NAME | VENUSYS MEDICAL SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2250521-79528 |
| BRAND NAME | FOTONA STARFORMER |
| MEDICAL DEVICE CATEGORY | MD 1400 - DEVICES FOR RADIATION THERAPY AND THERMO THERAPY |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Fotona StarFormer is device which is used for muscle strengthening on areas of glutes, abdomen, hamstring area, arms and pelvic floor using High Intensity magnetic Stimulation (HIMS). Fotona StarFormer will provide a pulsed magnetic field that will through its effect on muscles has been scientifically found that the technology of HIMS will result in increased muscle mass after multiple treatments on the same target location. During the treatment, the patient will either be lying on the therapeutic table or will be sitting on a chair. The procedure will last for about 30 minutes and can be performed for alternate days in a week. Do note that the treatment is non -invasive and the effectiveness of the treatment is not affected by clothes on the patient's body. The Fotona StarFormer magnetic system family consists of: 1) model M008-3T with commercial names - StarFomer - TightWave 2) model M008-5T with commercial name - IntimaWave Both variants are the same in terms of technical characteristics, basic safety and essential performance, but they differ at two areas, (number of channels and accessories) as below ; 1) StarFormer and TightWave have 4 channels and all accessories. 2) IntimaWave only have 2 channels and only have starformer intimawave chair accessories. |
| DEVICE INTENDED PURPOSE | The StarFormer Family of devices and their accessories are intended for magnetic stimulation in the field of Aesthetics, Urology, Gynecology, Rehabilitation, Physiotherapy, and Pain Management. |
| VALIDITY DATE OF REGISTRATION | 26/11/2021 - 25/11/2026 |