Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K143268 |
Device Name |
TENS AND POWERED MUSCLE STIMULATOR |
Applicant |
SHENZHEN AS-TEC TECHNOLOGY CO., LTD |
2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD., |
SHAJING |
SHENZHEN,
CN
518104
|
|
Applicant Contact |
CONNIE LI |
Correspondent |
SHANGHAI CV TECHNOLOGY CO., LTD |
ROOM 1706 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA |
SHANGHAI,
CN
201600
|
|
Correspondent Contact |
DORIS DONG |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/2014 |
Decision Date | 07/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|