Bioelectronics Corp (BIEL)

[toohot]

Thank you, srin. Good post!!!

Pulsed Showtwave Therapy devices were incorrectly classified as 'Type 3' Devices for decades, subjected to the most stringent controls that the FDA has for Medical Devices. Devices like Pacemakers are Class 3 because they are life sustaining.

BIEL received their first FDA Clearance in 2002 for use post Eyelid Surgery, but as a Class 3 Device it was available by Prescription Only. BIEL lobbied the FDA for years to move their safe, easy to use, non-life sustaining devices to a Class 2 status where they could gain further Clearances and have the possibility of 'Over the Counter' use.

In October of 2015 the FDA finally Reclassified BIEL's type of device, originally Product Code 'ILX', 'Shortwave Diathermy', into its own new Product Code, 'PQY', “Nonthermal Shortwave Therapy” (SWT). BIEL had their first Indications Cleared by the FDA, plantar fasciitis of the heel; and osteoarthritis of the knee, under this new category as OTC products in 2/2017.

This is where the PSWT clock begins.

On 1/31/2020 BIEL received the Musculoskeletal Pain FDA Clearance that its potential Partners were looking for. ActiPatch was now FDA Cleared for use on evey Muscle, Joint, Ligament and Tendon in the body.

ActiPatch is still the only Medical Device that has been granted 'PQY' status by the FDA.

In the 2.5 years that ActiPatch has been Cleared for Full Body Use they have signed these Partners:

KT Tape, The Wave, stand alone device, OEM Partner

Scott Specialties (sold by DonJoy), EME stand alone device, back wrap, knee sleeve, OEM Partner

SAI Brands, 10 'Powered By ActiPatch' products, OEM Partner

Airway Surgical (Canadian arm of SAI) 10 'Powered By ActiPatch' products, OEM Partner

STADA, ActiPatch Distribution Partner

PRIM Group, RecoveryRx Distribution Partner

e Novro Med S.A. de C.V., RecoveryRx Distribution Partner

Modern Development Medical Company, ActiPatch/RecoveryRx Distribution Partner


https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to