I looked at it and searched for the word Actipatch, bioelectronics corp, Actipatch OTC Clearance anytime now, but I did not find any words there. I put it in the trash box.
A number of reasons for dismissing it but you are right it is competition and makes people aware that devices exist to help with pain.
A) it is classified as TENS/ code NUF so not in the same category of device as Actipatch B) they can use predicate devices going back a few years (A whole chain of earlier models - Ascend, sensus etc) which makes clearance a formality compared to new devices c) its price