Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K120398 |
Device Name |
WITOUCH PRO |
Applicant |
HOLLYWOG, LLC |
2830 AMMICOLA HIGHWAY |
CHATTANOOGA,
TN
37406
|
|
Applicant Contact |
MICHAEL W TREAS |
Correspondent |
HOLLYWOG, LLC |
2830 AMMICOLA HIGHWAY |
CHATTANOOGA,
TN
37406
|
|
Correspondent Contact |
MICHAEL W TREAS |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/08/2012 |
Decision Date | 08/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|