510(k) K250266

Ceragem Automatic Thermal Massager (CGM MB-2401) by Ceragem Co., Ltd. — Product Code JFB

K250266 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "Ceragem Automatic Thermal Massager (CGM MB-2401)". The FDA issued a decision of Substantially Equivalent on July 11, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
January 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Physical Therapy, Multi Function
Device Class
Class II
Regulation Number
890.5880
Review Panel
PM
Submission Type