Device Classification Name |
stimulator, electrical, non-implantable, for incontinence
|
510(k) Number |
K121820 |
Device Name |
INWAVE |
Applicant |
ZYNEX MEDICAL, INC. |
9990 Park Meadows Dr. |
Lone Tree,
CO
80124
|
|
Applicant Contact |
JIM ARNOLD |
Correspondent |
ZYNEX MEDICAL, INC. |
9990 Park Meadows Dr. |
Lone Tree,
CO
80124
|
|
Correspondent Contact |
JIM ARNOLD |
Regulation Number | 876.5320
|
Classification Product Code |
|
Date Received | 06/21/2012 |
Decision Date | 08/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|