Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K210223 |
Device Name |
Transcutaneous Electrical Nerve Stimulator |
Applicant |
Top-Rank Health Care Co.,Ltd. |
Checun Village, Dongguan St. Shang-Yu District |
Shaoxing,
CN
312352
|
|
Applicant Contact |
James Zhou |
Correspondent |
Microkn Business Consulting (Shanghai) Co., Ltd. |
Room 1219, Block A, No3699, Gonghexin Road, Jingan District |
Shanghai,
CN
200040
|
|
Correspondent Contact |
Yuling Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 01/28/2021 |
Decision Date | 12/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|