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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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2023
Date Received
January 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromagnetic Stimulator, Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
PM
Submission Type

Intended to apply a magnetic-field induced electrical current to treat pain.

Other clearances by Tonica Elektronik A/S

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  • K221544 — MagVenture TMS Atlas Neuro Navigation System (March 17, 2023)
  • K193006 — MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
  • K173620 — Mag Vita TMS Therapy System w/Theta Burst Stimulation (August 14, 2018)
  • K172667 — MagVita TMS Therapy w/MagPro R20 (October 5, 2017)
  • K171967 — MagVita TMS Therapy System (July 25, 2017)
  • K171481 — MagVita TMS Therapy System (June 16, 2017)
  • K170114 — MagVita TMS Therapy - w/MagPro R20 (May 1, 2017)

Other clearances for product code QPL

  • K250309 — BTL-199 (August 7, 2025)
  • K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super (July 3, 2025)
  • K241785 — StarFormer (M008-3T) (March 27, 2025)
  • K233364 — Axon Therapy (January 10, 2024)
  • K210021 — Axon Therapy (June 11, 2021)