Another BIEL Classic, Musculoskeletal FDA Clearanc
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Posted On: 11/01/2021 5:14:27 PM
Another BIEL Classic, Musculoskeletal FDA Clearance
This was the "Brass Ring" that had eluded BIEL for 15 years.
The FDA's lack of knowledge regarding PEMF had resulted in ActiPatch receiving a Class 3 designation, lots of red tape and this is usually applied only to life sustaining medical devices.
In 2015 BIEL was successful in getting a FDA Reclassification for ActiPatch into a brand new product code, PQY, with a new name 'Pulsed Shortwave Therapy'.
This Reclassification designated ActiPatch as a Class 2 device which opened the door to an OTC Clearance.
It took another 4 years of back and forth with the FDA and hiring a prominent law firm with FDA experience to successfully navigate the FDA system.
Results, ActiPatch can now be sold as pain relief for every muscle and joint in the body on a OTC basis, no prescription required.
BioElectronics Announces FDA Market Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
FEBRUARY 3, 2020
BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the counter marketing clearance was granted for the drug free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”
The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, VP Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain in the back, knee, hips, wrists, elbow, ankle etc.”
Kelly Whelan, President of BioElectronics, stated “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.
https://www.bielcorp.com/bioelectronics-annou...etal-pain/
This was the "Brass Ring" that had eluded BIEL for 15 years.
The FDA's lack of knowledge regarding PEMF had resulted in ActiPatch receiving a Class 3 designation, lots of red tape and this is usually applied only to life sustaining medical devices.
In 2015 BIEL was successful in getting a FDA Reclassification for ActiPatch into a brand new product code, PQY, with a new name 'Pulsed Shortwave Therapy'.
This Reclassification designated ActiPatch as a Class 2 device which opened the door to an OTC Clearance.
It took another 4 years of back and forth with the FDA and hiring a prominent law firm with FDA experience to successfully navigate the FDA system.
Results, ActiPatch can now be sold as pain relief for every muscle and joint in the body on a OTC basis, no prescription required.
BioElectronics Announces FDA Market Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
FEBRUARY 3, 2020
BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the counter marketing clearance was granted for the drug free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”
The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, VP Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain in the back, knee, hips, wrists, elbow, ankle etc.”
Kelly Whelan, President of BioElectronics, stated “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.
https://www.bielcorp.com/bioelectronics-annou...etal-pain/
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