510(k) K243355

Ceragem Automatic Thermal Massager (CGM-MB-1902) by Ceragem Co., Ltd. — Product Code JFB

K243355 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "Ceragem Automatic Thermal Massager (CGM-MB-1902)". The FDA issued a decision of Substantially Equivalent on November 27, 2024. 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
November 27, 2024
Date Received
October 29, 2024
Clearance Type
Special
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