Monday, August 01, 2022 10:45:14 AM
ActiPatch remains the only Pulsed Shortwave Therapy device that has been Cleared by the FDA for Over the Counter sales in the US.
FDA 510k numbers K192234 and K152432.
K152432 Clears ActiPatch for OTC use in Plantar Fasciitis and Knee OA.
K192234 Clears ActiPatch for OTC use for Musculoskeletal Pain Relief in every Muscule, Joint, Bone, Tendon, Ligament, Cartilage in the body.
Companies wanting to enter the OTC Non-Drug PSWT/PEMF Medical Device Pain Relief Market with an FDA Cleared device have two options. OEM or Licensing with BIEL or spend years developing and getting FDA Clearance for their own device.
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