Sunday, May 30, 2021 9:30:37 AM
The FDA studied PEMF/PSWT for several years and in 2015 created a new Product Code, PQY, to more accurately identify PEMF/PSWT Products. This PQY Product Code reclassified PEMF/PSWT from a Class 3 Device to a Class 2 Device. This opened the door for a Over the Counter Clearance.
In 2017 BIEL submitted a 510k application with Clinical Data proving Safety and Efficacy. The FDA Cleared ActiPatch for Knee and Foot OTC use.
In 2020 BIEL submitted new Clinical Data to expand ActiPatch use to the Full Musculoskeletal System. The FDA agreed and granted ActiPatch Clearance for Full Body OTC use.
Thanks for your Opinion but I will trust the FDA's Opinion that ActiPatch is a Safe and Effective Pain Reliever.
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