Device Classification Name |
stimulator, muscle, powered
|
510(k) Number |
K171978 |
Device Name |
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 |
Applicant |
Shenzhen Dongdixin Technology Co., Ltd. |
No. 3 Building Xilibaimang Xusheng Industrial Estate |
Nanshan |
Shenzhen,
CN
518108
|
|
Applicant Contact |
Siping Yuan |
Correspondent |
Shenzhen Dongdixin Technology Co., Ltd. |
No. 3 Building Xilibaimang Xusheng Industrial Estate |
Nanshan |
Shenzhen,
CN
518108
|
|
Correspondent Contact |
Siping Yuan |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/30/2017 |
Decision Date | 10/02/2017 |
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
|
|
|