FDA Product Code ILO: Pack, Hot Or Cold, Water Circulating
Leading manufacturers include Baxter Healthcare Corp, Pain Management Technologies, Inc. and Zimmer, Inc..
93
Total
93
Cleared
132d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Pack, Hot Or Cold, Water Circulating Devices (Product Code ILO)
93 devices
Cleared
Jun 10, 2022
Armory Motion
Pain Management Technologies, Inc.
Neurology
259d
Cleared
Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
Smith & Nephew, Inc.
Physical Medicine
62d
Cleared
Aug 18, 1995
THERMOCOOL SYSTEM
Zimmer, Inc.
Physical Medicine
198d
Cleared
Sep 11, 1991
HYPER-K HEAT SYSTEM
Baxter Healthcare Corp
Physical Medicine
85d
Cleared
Feb 13, 1991
K-MODULE II HEAT THERAPY SYSTEM
Baxter Healthcare Corp
Physical Medicine
35d
About Product Code ILO - Regulatory Context
510(k) Submission Activity
93 total 510(k) submissions under product code ILO since 1976, with 93 receiving FDA clearance (average review time: 132 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.