Cleared Traditional

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption

K230014 · Tonica Elektronik A/S · Physical Medicine
Aug 2023
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K230014 is an FDA 510(k) clearance for the MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, a Electromagnetic Stimulator, Pain Relief (Class II — Special Controls, product code QPL), submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on August 25, 2023, 234 days after receiving the submission on January 3, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K230014 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2023
Decision Date August 25, 2023
Days to Decision 234 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code QPL — Electromagnetic Stimulator, Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.