EMS (FlexPulse, MagnaCore, Magnetika)
K-Number: K241601 · 2025-02-25
Decision Date2025-02-25
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
EMS (FlexPulse, MagnaCore, Magnetika) is a medical device manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation). It received FDA 510(k) clearance on 2025-02-25 under approval number K241601. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EMS (FlexPulse, MagnaCore, Magnetika)?
EMS (FlexPulse, MagnaCore, Magnetika) is a medical device that received FDA 510(k) clearance on 2025-02-25. It is manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation). The 510(k) number is K241601.
When was EMS (FlexPulse, MagnaCore, Magnetika) approved by the FDA?
EMS (FlexPulse, MagnaCore, Magnetika) received FDA 510(k) clearance on 2025-02-25, under approval number K241601.
What company makes EMS (FlexPulse, MagnaCore, Magnetika)?
EMS (FlexPulse, MagnaCore, Magnetika) is manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation).
What is the FDA product code for EMS (FlexPulse, MagnaCore, Magnetika)?
The FDA product code for EMS (FlexPulse, MagnaCore, Magnetika) is NGX.
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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.