FDA 510(k) Applications for Medical Device Product Code "IRN"
(Device, Warning, Overload, External Limb, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K023161 ANDANTE MEDICAL DEVICE, LTD. SMARTSTEP SYSTEM 12/10/2002
K060150 ANDANTE MEDICAL DEVICES LTD. SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM 02/23/2006
K962591 CLEVELAND MEDICAL DEVICES, INC. FOOT WEIGHT ALARM 12/04/1996
K955034 IMPACT MONITORS, INC. FORCEGUARD 04/10/1996
K991313 ORTHOPEDIC TECHNOLOGY RESEARCH, INC. ACCUTRED SHOE 06/23/1999
K960307 ORTHOPEDIC TECHNOLOGY RESEARCH, INC. INDEX SHOE 06/27/1996


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