Bioelectronics Corp (BIEL)

[srinsocal]

ENDV Sofpulse used as Predicate Device in 2019 RecoveryRx Post-Op Clearance

<<<<<<< Wouldn’t their product be a predicate device making it easier to apply?>>>>>>>

In BIEL's 2019 RecoveryRx Clearance, K190251, for Post-Op Pain Relief both ActiBand (predesessor to the ActiPatch) and Sofpulse were used as Predicate Devices.

So, the FDA already has experience with a higher power wearable PEMF/PSWT device and accepted it as a Predicate for RecoveryRx.

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf