Change on FDA Establishment Registration & Device Listing

Both RecoveryRx and ActiPatch have added "Complaint File Establishment" to their 'Current Information' on the Device Listing.


BIOELECTRONICS CORPORATION MD/USA
3004837702 2025
diathermy, shortwave, for use other than applying therapeutic deep heat - RecoveryRx Model 077; RecoveryRx Model 088
Manufacturer; Specification Developer; Complaint File Establishment


BIOELECTRONICS CORPORATION MD/USA
3004837702 2025
nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain - ActiPatch® Model 077; ActiPatch® Model 088
Manufacturer; Specification Developer; Complaint File Establishment


KT Health is the only other company involved with PEMF/PSWT on the Device List that has a 'Complaint File', which has been there for years.

I am not sure why there is now a need for this 'Complaint File' but something has changed.