Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K172919 |
Device Name |
EV-804 OTC Pain Relief TENS |
Applicant |
Everyway Medical Instruments Co., Ltd. |
3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. |
Shenkeng Dist |
New Taipei City,
TW
22203
|
|
Applicant Contact |
Paul Hung |
Correspondent |
Everyway Medical Instruments Co., Ltd. |
3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. |
Shenkeng Dist |
New Taipei City,
TW
22203
|
|
Correspondent Contact |
Paul Hung |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/25/2017 |
Decision Date | 04/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|