Letter from FDA CDRH to BioElectronics Corporation This document has attachments
- Attachment Title : Letter from FDA CDRH to BioElectronics Corporation
Other by FDA on 06/02/2014 ID: FDA-2012-N-0378-0052
ok. so the device is now classified as Non thermal sw diathermy. Special controls needed as in limited studies, BUT it proved to be harmless and must work. About 6 companies got this letter , even one who has PEMF but not in a portable form. I spoke to that man years ago and he claimed the miniature versions can't work , and only large hospital based equipment are effective. His company was shut down by the SEC and is now private. He was looking for investors of big capital 3 years ago. I hope by August we get some type of OTC clearance but probably this will drag on into 2015. Where is MTorornto ....swimming in Lake Ontario ?