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IRN — Device, Warning, Overload, External Limb, Powered Class II

FDA Device Classification

Classification Details

Product Code
IRN
Device Class
Class II
Regulation Number
890.5575
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060150andante medical devicesSMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEMFebruary 23, 2006
K023161andante medical deviceSMARTSTEP SYSTEMDecember 10, 2002
K991313orthopedic technology researchACCUTRED SHOEJune 23, 1999
K962591cleveland medical devicesFOOT WEIGHT ALARMDecember 4, 1996
K960307orthopedic technology researchINDEX SHOEJune 27, 1996
K955034impact monitorsFORCEGUARDApril 10, 1996
K950656orbitec technologiesPED ALERTOctober 25, 1995
K931517lenjoy engineeringSAFE-STEPMarch 10, 1995
K882974boulder impact monitorsFORCE GUARD INovember 4, 1988
K792241colmedPELIMITNovember 30, 1979
K770405synthes (usa)OVERLOAD WARNING DEVICEMarch 10, 1977