510(k) K100521

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS by Mego Afek AC , Ltd. — Product Code JOW

K100521 is an FDA 510(k) premarket notification submitted by Mego Afek AC , Ltd. for the device "COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS". The FDA issued a decision of Substantially Equivalent on May 14, 2010. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Mego Afek AC , Ltd. has 16 other 510(k) clearances on record.