Replies to post #103679 on Bioelectronics Corp (BIEL)

[Steve43]

Was it cleared for OTC before, no it wasn't. Was it eligible to be sold or advertised in the U.S. OTC , no it wasn't. Is it now available in the U.S Market which is considered the "Epicenter of the Fitness World" with a population of over 300 million, yes it is. So BIEL is now a truly Global Business, yepper. JMHO No this is not the EU or Asia this is the heart of the Health and Wellness World bent on alternatives to drug addicting pain relievers which now has a new addition. The Holy Grail known as the FDA has opened the door after 8 years of BS yes the Agency that was said to never grant acceptance to BIEL, yup it was said it wasn't on the FDA radar every day. So unless one now believes the FDA to be irrelevant it is a whole new ball game and we will see. Yup acceptance from the Golden Rule of acceptance.

[seven-up]

Yep that-is-FUNNY-ELASTIC-BANDAGE-IS-CONSIDER ADJUNCTIVE TREATMENT,yep Biel's new packaging includes an Elastic Bandage to hold it on LOL

FDA 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: 03/20/2017

Product Classification

Device Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Regulation Description Shortwave diathermy.
Definition Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Physical State Nonthermal shortwave therapy devices which include applicators applied to the body.
Technical Method Uses pulsed electromagnetic energy at 13.56 MHz or 27.12 MHz delivered treatment.
Target Area To be applied over body areas and joints such as the knee and ankle; however, the device should not be applied directly over areas with active implantables.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product Code PQY
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(k)
Regulation Number 890.5290
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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Page Last Updated: 03/20/2017

[DewmBoom]

Buy it at the cheap right here and don't the opportunity of making 700% or more!!! Last time you were calling for 0.0002 but I hope you made some money here.

It is now cleared and the rest is history. You will see at Walgreens US soon!!!!