510(k) K243644

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) by Ceragem Co., Ltd. — Product Code JFB

K243644 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)". The FDA issued a decision of Substantially Equivalent on January 8, 2025. 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.