510(k) K220572

Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 by Ceragem Co., Ltd. — Product Code JFB

K220572 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702". The FDA issued a decision of Substantially Equivalent on June 17, 2022. 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
June 17, 2022
Date Received
February 28, 2022
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