Clearance Summary
Therapy EC, Therapy XT received FDA 510(k) clearance under submission number K232813, sponsored by Dmc Importacao E Exportacao DE Equipamentos Ltda. 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 2024-12-19.
- Submission: K232813
- Applicant / Sponsor: Dmc Importacao E Exportacao DE Equipamentos Ltda
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2024-12-19
Classification & Regulation
This clearance is catalogued under FDA product code NHN and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.