IQI · Class I · 21 CFR 890.3475

FDA Product Code IQI: Orthosis, Limb Brace

Leading manufacturers include Fred Sammons, Inc., Conphar, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

52
Total
52
Cleared
32d
Avg days
1976
Since

FDA 510(k) Cleared Orthosis, Limb Brace Devices (Product Code IQI)

52 devices
1–24 of 52
Cleared Jun 24, 1983
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542
Fred Sammons, Inc.
Physical Medicine · 43d
Cleared Jan 14, 1983
VARIOUS SUPPORTS AND SPLINTS
K823812
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jun 11, 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 11, 1982
OBTHOSES
K821641
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Jun 12, 1981
FOREARM & KNEE STRAPS
K811490
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Mar 04, 1981
LIMB ORTHOSIS
K810443
Fred Sammons, Inc.
Physical Medicine · 13d
Cleared Sep 16, 1980
C-SPLINT
K802104
Cutter Laboratories, Inc.
Physical Medicine · 13d
Cleared Aug 07, 1980
BAUER & BLACK RIGID WRIST BRACE
K801701
Bd Becton Dickinson Vacutainer Systems Preanalytic
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Jul 24, 1979
SECUTE ELBOW BAND
K791248
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX WRIST BRACE
K791249
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX KNEE BAND
K791266
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX ANKLE BAND
K791267
Conphar, Inc.
Physical Medicine · 18d
Cleared Jun 20, 1979
CAST BRACE COMPONENTS
K791057
3M Company
Physical Medicine · 12d
Cleared Jul 31, 1978
FOOT POSITIONER
K781206
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Feb 24, 1978
ORTHOSISES DEVICES
K780225
Biomet, Inc.
Physical Medicine · 15d
Cleared Jan 17, 1978
BRACE, TENNIS ELBOW
K780053
Bd Becton Dickinson Vacutainer Systems Preanalytic
Physical Medicine · 8d
Cleared Nov 11, 1976
DEVON KNEE STRAP
K760950
Devon Industries, Inc.
Physical Medicine · 10d
Cleared Jul 26, 1976
KNEE AID
K760002
Zimmer, Inc.
Physical Medicine · 61d

About Product Code IQI - Regulatory Context