Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K160508 |
Device Name |
Electronic Pulse Stimulator |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
NO.9 SHUANGYUAN ROAD, BADACH HI-TECH ZONE |
SHIJINGSHAN DISTRICT |
Beijing,
CN
100041
|
|
Applicant Contact |
Lei Chen |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
NO.9 SHUANGYUAN ROAD, BADACH HI-TECH ZONE |
SHIJINGSHAN DISTRICT |
Beijing,
CN
100041
|
|
Correspondent Contact |
Lei Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/24/2016 |
Decision Date | 11/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|