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510(k) K210021

Axon Therapy by Neuralace Medical, Inc. — Product Code QPL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 11, 2021
Date Received: January 4, 2021
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.