Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K243355

Ceragem Automatic Thermal Massager (CGM-MB-1902)

510(k) number
K243355
Device name
Ceragem Automatic Thermal Massager (CGM-MB-1902)
Applicant
Ceragem Co., Ltd. KR
Product code
JFB — Table, Physical Therapy, Multi Function
Decision date
2024-11-27
Date received
2024-10-29
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.