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FDA 510(k)

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

K-Number: K230014 · 2023-08-25

ApplicantTonica Elektronik A/S
Decision Date2023-08-25
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2023-08-25 under approval number K230014. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K230014.

When was MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption approved by the FDA?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption received FDA 510(k) clearance on 2023-08-25, under approval number K230014.

What company makes MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

The FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is QPL.

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Other Devices by Tonica Elektronik A/S

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K210021Axon TherapyNeuralace Medical, Inc. K233364Axon TherapyNeuralace Medical, Inc. K250309BTL-199BTL Industries, Inc. K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)The Magstim Company Limited K241785StarFormer (M008-3T)Fotona D.O.O.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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