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510(k) K250286

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) by The Magstim Company Limited — Product Code QPL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 3, 2025
Date Received: January 31, 2025
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.