INWAVE


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

Correspodent Contact jim arnold
Regulation Number 876.5320
Classification Product Code
KPI  
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