Bioelectronics Corp (BIEL)

[walker_429]

You keep posting complete bullshit that you continue to fabricate from your low IQ and defective comprehension ability.
It doesn't matter how many times this has been explained to you with proof, you choose to continue to just ignore it.
Hmmm..... Can we say Cognitive Dissonance with superiority complex and Narcissism?

Follow the bouncing ball......

No need for a 510(k) application with the new brand name of RecoveryRx Xtra as the FDA already considers it acceptable under the already cleared model 088 of Actipatch / RecoveryRX . Biel submitted a Q submission for this modified model 088 ( Higher Frequency / Higher Power ) and the FDA gave guidance in which they were able to use the device in the Ilfeld and Stanford clinical trials without needing to submit an IDE application. Just a thought, modified can be antenna size/shape and the internal workings of the battery unit possibly higher voltage ( 3v to a 4.5v or 6v ) . Actiband I believe was a 6 volt but was bulky. Batteries have shrunk since then.

A new expedited 510(k) application will be submitted as the requirement for a new indication for the specific body part of the thumb and wrist resulting from the Stanford study NCT05315297 which used the modified model 088 Higher Frequency device.

The patents are still there. The RecoveryRx Xtra falls under the current patents. What has expired is the government ( US Inc ) which includes the USPTO and EXIM Bank.

Both the Stanford study NCT05315297 and the Dr. Brian Ilfeld study NCT05399355 - Pulsed Electromagnetic Fields for Postoperative Analgesia used the RecoveryRx Xtra. Because the actual brand name for the 50% more powerful device has not been established yet, they list it as Active Pulsed Shortwave Treatment with BioElectronics Model 088 .

Have a good weekend feces boy.....lol!