Bioelectronics Corp (BIEL)

[srinsocal]

Yep pinhigh. BIEL has the only FDA Cleared OTC PSWT Device

The FDA created a new Product Code, PQY, for the ActiPatch in 2017 and it is still the only PSWT/PEMF FDA Cleared OTC Device in the world.


1 to 2 of 2 Results
ProductCode: PQY Decision Date To: 08/19/2022

Actipatch BioElectronics Corporation K192234 01/31/2020
Actipatch(R) BIOELECTRONICS CORPORATION K152432 02/03/2017


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm


Anyone who wants to sell PSWT/PEMF FDA Cleared Devices OTC in the US has to Partner/License with BIEL or develope their own device and wait in line at the FDA.

FDA PQY Establishment Registration Device Listing

AIRWAY SURGICAL APPLIANCES LTD. CANADA
9611956 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler (BIEL OEM Partner)

BIOELECTRONICS CORPORATION MD/USA
3004837702 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain - ActiPatch
Manufacturer
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Manufacturer; Specification Developer

KT Health, LLC UT/USA
3007282994 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Complaint File Establishment (BIEL OEM Partner)

SCOTT SPECIALTIES, INC. KS/USA
1933909 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler (BIEL OEM Partner)

SCOTT SPECIALTIES, INC. KS/USA
1917910 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler (BIEL OEM Partner)

SURGICAL APPLIANCE INDUSTRIES, INC. OH/USA
1511629 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler (BIEL OEM Partner)