DRX5000


Device Classification Name

equipment, traction, powered

510(k) Number K023160
Device Name DRX5000
Original Applicant
AXIOM USA. INC
3830 gunn hwy
tampa, 
FL 
33624

Original Contact jim gibson
Regulation Number 890.5900
Classification Product Code
ITH  
Date Received 09/23/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No