Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K171599 |
Device Name |
WiTouch Pro, WiTouch, Neubac |
Applicant |
Hollywog LLC |
2830 Amnicola Highway |
chattanooga,
TN
37406
|
|
Applicant Contact |
michael treas |
Correspondent |
Hollywog LLC |
2830 Amnicola Highway |
chattanooga,
TN
37406
|
|
Correspondent Contact |
michael treas |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2017 |
Decision Date | 09/22/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|