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  4. BioElectronics Corporation (BIEL) Message Board

Looks Like a OTC RecoveryRx in US is coming The

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Post# of 8390
(Total Views: 443)
Posted On: 04/30/2021 3:38:30 PM
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Posted By: swordfish
Looks Like a OTC RecoveryRx in US is coming

The November CE authorization was for both ActiPatch and RecoveryRx as an OTC Product.

FREDERICK, MD, Nov. 12, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that it has received the CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx® Pulsed Shortwave Therapy (PSWT) medical devices.

The ActiPatch is indicated for the treatment of general musculoskeletal/soft-tissue pain, while the RecoveryRx is indicated for the treatment of postoperative pain. These wearable devices can now be sold over the counter in 33 European Union (EU) countries , and many other non-EU countries like Australia that recognize the CE mark.
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In March 2021 BIEL registered RecoveryRx in the FDA GUDID Database under the PQY Product Code. PQY is the OTC Product Code created for ActiPatch in 2017. RecoveryRx has been FDA Cleared for prescription use under Product Code ILX since 2019 for Post Op Pain.

An OTC Clearance should greatly increase the use of RecoveryRx.

https://accessgudid.nlm.nih.gov/devices/search?query=PQY


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