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510(k) K192234

ActiPatch by Bioelectronics Corporation — Product Code PQY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 31, 2020
Date Received: August 19, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Device Class: Class II
Regulation Number: 890.5290
Review Panel: PM
Submission Type

Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.