Replies to post #110072 on Bioelectronics Corp (BIEL)

[DewmBoom]

Biel is the only company in the world that has a PEMF wearable device clearance to sell in the United States of America Over the Counter without a prescription.

The Actipatch is a Class II device that cleared to sell OTC for the adjunctive treatment of knee and foot pain. The FDA created a special category to clear the Actipatch OTC because of its significance!!!!

The Actipatch will soon get the back pain clearance and the general use clearance. This will happen as soon as Oxford University completes the Backpain Clinical Trial:

What is Unique About the Actipatch

Zero Competition. Literally, there is no other OTC PEMF wearable devices available for adjunctive treatment

Zero Side Effects
Full Patent Protection
Clinical Trials with Real World Data that shows significant PAIN REDUCTION

The Actipatch provides a huge market barrier to any potential competition with their trial device of one week at $9.95. This must be frustrating to the potential competitors because Biel destroyed them. Biel also spent a minimal amount of money to reach this milestone.

That is why the success of Biel is irreversible. That is why Dewboom is treating Biel as an early retirement stock by the end of 2018!!!!!

THINK ABOUT AND DIVE IN. For long term investors, there isn't much difference between 6, 7, 8, 10, 20, etc....

[HORUS]

I'm no. It went from class3 thermal the reclassified as class 2 non thermal. Wow

[seven-up]

LOL completely wrong the post related to Actipatch FDA cleared for OTC GEEEEEEEEZZZZZZ. The act referred to has been meet that is why Actipatch is selling in the USA, simple facts. Misinformation post. Like I said better contact the FDA they seem to disagree with the assessment posted related to Actipatch.

FDA, U.S. Food and Drug Administration(The U.S. mean United States of America, not Canada or Europe LOL)

510(k) Premarket Notification

Device Classification Name Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
510(K) Number K152432
Device Name ActiPatch(R)
Applicant
BIOELECTRONICS CORPORATION
4539 Metropolitan Court
Frederick, MD 21704
Applicant Contact Andrew Whelan
Correspondent
BIOELECTRONICS CORPORATION
4539 Metropolitan Court
Frederick, MD 21704
Correspondent Contact Andrew Whelan
Regulation Number 890.5290
Classification Product Code
PQY
Date Received 08/27/2015
Decision Date 02/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed By Third Party No
Combination Product No
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Page Last Updated: 06/19/2017


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152432