Replies to post #57051 on Bioelectronics Corp (BIEL)

[richsean]

III. The Final Order

Under section 513(e) of the FD&C Act,
FDA is adopting its findings as published in the preamble to the proposed order with the modifications discussed in Section II of this final order. FDA is issuing this final order to reclassify shortwave diathermy (SWD)
for adjunctive use in the palliative treatment of postoperative pain and
edema in superficial soft tissue by means other than the generation of deep
heat within body tissues from class III to class II, rename the device ‘‘nonthermal shortwave therapy’’

[ken6o]

GREAT JOB richsean!!!! I just read our section and it looks great for us. There is some marketing/sales pieces that hinge on the 501k clearance but still a HUGE milestone here!!!!