NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM


Device Classification Name

stimulator, muscle, powered

510(k) Number K111279
Device Name NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
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 890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received 05/05/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No