Device Classification Name |
table, physical therapy, multi function
|
510(k) Number |
K202113 |
Device Name |
Ceragem Automatic Thermal Massager, Model CGM-MB-1901 |
Applicant |
Ceragem Co, Ltd. |
10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu |
Cheonan-Si,
KR
31041
|
|
Applicant Contact |
Hyeonggeun Hwang |
Correspondent |
LK Consulting Group USA, Inc. |
1150 Roosevelt, STE 200 |
Irvine,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 890.5880
|
Classification Product Code |
|
Date Received | 07/30/2020 |
Decision Date | 03/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|