Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K183674 |
Device Name |
Electronic Pulse Stimulator |
Applicant |
Shenzhen Leading Perfection Technology Co., Ltd |
4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi |
Road, Jiuwei |
Shenzhen,
CN
518101
|
|
Applicant Contact |
Simon Hou |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center, |
Guimiao Road |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Rain Yip |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/27/2018 |
Decision Date | 10/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|