IRN · Class II · 21 CFR 890.5575

FDA Product Code IRN: Device, Warning, Overload, External Limb, Powered

Leading manufacturers include Orthopedic Technology Research, Inc., Andante Medical Device, Ltd. and Andante Medical Devices , Ltd..

11
Total
11
Cleared
160d
Avg days
1977
Since

FDA 510(k) Cleared Device, Warning, Overload, External Limb, Powered Devices (Product Code IRN)

11 devices
1–11 of 11
Cleared Feb 23, 2006
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
K060150
Andante Medical Devices , Ltd.
Physical Medicine · 34d
Cleared Dec 10, 2002
SMARTSTEP SYSTEM
K023161
Andante Medical Device, Ltd.
Physical Medicine · 78d
Cleared Jun 23, 1999
ACCUTRED SHOE
K991313
Orthopedic Technology Research, Inc.
Physical Medicine · 68d
Cleared Dec 04, 1996
FOOT WEIGHT ALARM
K962591
Cleveland Medical Devices, Inc.
Physical Medicine · 155d
Cleared Jun 27, 1996
INDEX SHOE
K960307
Orthopedic Technology Research, Inc.
Physical Medicine · 157d
Cleared Apr 10, 1996
FORCEGUARD
K955034
Impact Monitors, Inc.
Physical Medicine · 160d
Cleared Oct 25, 1995
PED ALERT
K950656
Orbitec Technologies Corp.
Physical Medicine · 254d
Cleared Mar 10, 1995
SAFE-STEP
K931517
Lenjoy Engineering, Inc.
Physical Medicine · 714d
Cleared Nov 04, 1988
FORCE GUARD I
K882974
Boulder Impact Monitors, Inc.
Physical Medicine · 112d
Cleared Nov 30, 1979
PELIMIT
K792241
Colmed, Ltd.
Physical Medicine · 23d
Cleared Mar 10, 1977
OVERLOAD WARNING DEVICE
K770405
Synthes (Usa)
Physical Medicine · 7d

About Product Code IRN - Regulatory Context