Things Heating Up in the Prescription PEMF Market

Hi-Dow International, a TENS/EMS company, has received a 510k Clearance for a Pulsed Electromagnetic Field Wrap in the ILX Product Code, Prescription Only.

I have been trying to get details for the last 3 months but everyone is tight lipped on this one. Hi-Dow did not publish the traditional 'Summary Document' with the 510k Clearance so there is no info on the Predicate, Specifications , ect.. No entry yet in the FDA Device Registration Database.

Hi-Dow says that these products will not be sold on their website, only Marketing is through insurance companies. This sounds odd as most insurance companies still consider PEMF as investigational and don't cover its use.

Since Hi-Dow has no experience in PEMF, IMO, there is a good chance this is a BIEL OEM/Licensing Partner. Why reinvent a patented Medical Device when you have no expertise in the tech and can buy the rights to use a proven one.


TrueStim Pulsed Electromagnetic Field Wrap Black Neck Wrap,
#HD-08D(TSG-D1)
https://accessgudid.nlm.nih.gov/devices/00851640007931


TrueStim Pulsed Electromagnetic Field Wrap,,LUMBAR WRAP Black
#HD-08A(TSG-A1)
https://accessgudid.nlm.nih.gov/devices/00851640007900


TrueStim Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black
#HD-08C(TSG-C1)
https://accessgudid.nlm.nih.gov/devices/00851640007924


TrueStim Pulsed Electromagnetic Field Wrap, Black, Knee Wrap
#HD-08B(TSG-B1)
https://accessgudid.nlm.nih.gov/devices/00851640007917