Clearance Summary
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) received FDA 510(k) clearance under submission number K231318, sponsored by Beijing Adss Development Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2023-07-07.
- Submission: K231318
- Applicant / Sponsor: Beijing Adss Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2023-07-07
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.