NEOGENESYS 2K


Device Classification Name

interferential current therapy

510(k) Number K022433
Device Name NEOGENESYS 2K
Original Applicant
SANEXAS INTL. GMBH
200 ne mulberry
lee’s summit, 
MO 
64086

Original Contact gene kelly
Classification Product Code
LIH  
Subsequent Product Codes
GZJ   IPF  
Date Received 07/25/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No