InvestorsHub Logo
icon url

The_Expert

11/08/09 9:02 PM

#60 RE: mick #59

510K FILING DATES AND STATUS:

1. Allay(TM) Patch Product. This indication be used for the pain reduction associated with dysmenorrhea (period pain and cramps). Coupled with this is a second FDA filing was for a reclassification of the Company's technologies from Class III to Class II. Filed with FDA: June 15, 2009 Status: Bioelectronics has received and answer questions from the FDA early to mid August 2009 and possible in early October 2009. The early October questions and answers about diagrams are unconfirmed. Bioelectronics is now waiting for the a further responses or approval from the FDA.

2. ActiPatch Therapy Product. This indication will be used for the treatment of heel and foot pain, and pain relief relative to general musculoskeletal complaints. Filed with FDA: September 22, 2009 Status: Waiting for the first response from the FDA.