510(k) K230014

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption by Tonica Elektronik A/S — Product Code QPL

K230014 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption". The FDA issued a decision of Substantially Equivalent on August 25, 2023. The device falls under product code QPL (Electromagnetic Stimulator, Pain Relief), a Class II device regulated under 21 CFR 882.5890. Tonica Elektronik A/S has at least 10 other 510(k) clearances on record.