Bioelectronics Corp (BIEL)

[WHELANer]

Go to FDA website and read letter to AW for 510(K) # : K152432 . There is a nine page comparison of Actiband, Orthocor, Ivivi and Actpatch. Actipatch used the other 3 as predicate devices to gain approval. Duration of use and different pulsation times are used on these 27.12MHZ devices. Only BIEL has OTC for now.

Click on the Summary of of page with the 510(K) # and you can read the letter from Feb.2017 with the charts that follow.