Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K133108 |
Device Name |
FIT BELT |
Applicant |
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED |
4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE |
XIXIANG ROAD, BOA'AN DISTRICT |
SHENZHEN,
CN
518102
|
|
Applicant Contact |
XU JIAN HUA |
Correspondent |
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED |
4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE |
XIXIANG ROAD, BOA'AN DISTRICT |
SHENZHEN,
CN
518102
|
|
Correspondent Contact |
XU JIAN HUA |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 08/05/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|