BioElectronics files 510(k) market clearance application with FDA for ActiPulse device

By Lisa Kerner

Erie, Pa., May 16 - BioElectronics Corp. said it has filed a 510(k) market clearance application with the Food and Drug Administration for the indication of use for its new ActiPulse device as "the adjunctive use in the palliative treatment of post operative pain and edema in superficial soft tissue."

The new device and indication are expected to broaden the company's scope into palliative treatment, according to a company news release.

BioElectronics, based in Frederick, Md., manufactures and sells ActiPatch, a drug-free anti-inflammatory patch with an embedded battery operated microchip.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.