Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K162479 |
Device Name |
Smart Pain Reliever, Model LT5019 |
Applicant |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE |
NANSHAN |
SHENZHEN,
CN
518108
|
|
Applicant Contact |
TRUMAN SHEN |
Correspondent |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE |
NANSHAN |
SHENZHEN,
CN
518108
|
|
Correspondent Contact |
TRUMAN SHEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/06/2016 |
Decision Date | 02/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|