300 PV COMPLETE ELECTROTHERAPY SYSTEM


Device Classification Name

stimulator, muscle, powered

510(k) Number K021100
Device Name 300 PV COMPLETE ELECTROTHERAPY SYSTEM
Original Applicant
EMPI
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZI   GZJ   LIH  
Date Received 04/04/2002
Decision Date 06/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No