Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K171026 |
Device Name |
Mytens Model: BW-TSX |
Applicant |
Bewell Connect Corp. |
Suite 410, 185 Alewife Brook Parkway |
Cambridge,
MA
02138
|
|
Applicant Contact |
Jacob Chen |
Correspondent |
Bewell Connect Corp. |
Suite 410, 185 Alewife Brook Parkway |
Cambridge,
MA
02138
|
|
Correspondent Contact |
Jacob Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/05/2017 |
Decision Date | 11/01/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|