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Posted On: 04/07/2025 2:33:56 PM
Post# of 8295
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.
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.
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