510(k) K202113

Ceragem Automatic Thermal Massager, Model CGM-MB-1901 by Ceragem Co., Ltd. — Product Code JFB

K202113 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "Ceragem Automatic Thermal Massager, Model CGM-MB-1901". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Ceragem Co., Ltd. has at least 6 other 510(k) clearances on record.