Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K181849 |
Device Name |
iStim S2 OTC Pain Relief TENS |
Applicant |
Everyway Medical Instruments CO., LDT. |
3 Fl., No. 5, Lane 155, Sec.3 Beishen Rd. |
Shenkeng Dist. |
New Taipei City,
TW
22203
|
|
Applicant Contact |
Paul Hung |
Correspondent |
DuVal & Associates |
825 Nicollet Mall, Suite 1820 |
Minneapolis,
MN
55402
|
|
Correspondent Contact |
Aaron Hage |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/11/2018 |
Decision Date | 08/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|