SMARTSTEP SYSTEM


Device Classification Name

device, warning, overload, external limb, powered

510(k) Number K023161
Device Name SMARTSTEP SYSTEM
Original Applicant
ANDANTE MEDICAL DEVICE, LTD.
117 ahuzah st.
ra’ananna, 

IL

43373

Original Contact orly maor
Regulation Number 890.5575
Classification Product Code
IRN  
Date Received 09/23/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No