IRN · Class II · 21 CFR 890.5575

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

Leading manufacturers include Orthopedic Technology Research, Inc., Synthes (Usa) and Impact Monitors, Inc..

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 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 Mar 10, 1977
OVERLOAD WARNING DEVICE
K770405
Synthes (Usa)
Physical Medicine · 7d

About Product Code IRN - Regulatory Context