510(k) K122480

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST by International Biophysics Corporation — Product Code BYI

K122480 is an FDA 510(k) premarket notification submitted by International Biophysics Corporation for the device "INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST". The FDA issued a decision of Substantially Equivalent on March 27, 2013. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. International Biophysics Corporation has at least 2 other 510(k) clearances on record.