IMD · Class I · 21 CFR 890.5710

FDA Product Code IMD: Pack, Hot Or Cold, Disposable

Leading manufacturers include Prism Technologies, Inc., Omni Therm, Inc. and Signal West.

82
Total
82
Cleared
75d
Avg days
1976
Since
82 devices
25–48 of 82
Cleared Jun 01, 1995
TEMPRA HEAT PACK
K951383
Tempra Technology, Inc.
Physical Medicine · 66d
Cleared May 02, 1994
POLY-MEDICS HEAT PACK
K941245
Biomet, Inc.
Physical Medicine · 48d
Cleared Mar 31, 1994
OMNI WARM GEL PACKS
K936084
Omni Therm, Inc.
Physical Medicine · 100d
Cleared Mar 07, 1994
INSTANT HOT OR COLD DISPOSABLE PACK
K935569
Cryopak Industries, Inc.
Physical Medicine · 109d
Cleared Mar 07, 1994
CERTI HEAT INSTANT HEAT COMPRESS
K940336
Certified Safety Mfg., Inc.
Physical Medicine · 41d
Cleared Feb 03, 1994
TRANSWARMER
K934631
Prism Technologies, Inc.
Physical Medicine · 132d
Cleared Feb 02, 1994
KACEY DISPOSABLE INFANT HEEL WARMER
K934673
K & C Medical, Inc.
Physical Medicine · 125d
Cleared Jul 29, 1993
PERI-K PAD COLD PACK
K920760
Baxter Healthcare Corp
Physical Medicine · 526d
Cleared May 26, 1993
ANAGO FEM-COOL/FEM-COOL PETITE
K926137
Anago, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
ANAGO WARM PACK
K926589
Anago, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
ANAGO DISPOSABLE INSTANT COLD PACK
K926590
Anago, Inc.
Physical Medicine · 170d
Cleared Feb 11, 1992
CURAD KID SIZE INSTANT COLD PACK
K920252
Kendall Healthcare Products Co. Div.Of Tyco Health
Physical Medicine · 21d
Cleared Oct 02, 1991
INSTANT WARM GEL PACK
K912715
Prism Technologies, Inc.
Physical Medicine · 106d
Cleared Dec 06, 1990
SHUR-LOCK ICE WRAP SYSTEM
K904819
Conco Medical Co.
Physical Medicine · 43d
Cleared Jul 25, 1990
LIBERTY HOT PACK AND LIBERTY KOLD PACK
K902839
Liberty Ent.
Physical Medicine · 27d
Cleared May 03, 1990
INSTANT ICE PACK
K901834
Impact Packaging Corp.
Physical Medicine · 9d
Cleared May 01, 1990
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778
3M Company
Physical Medicine · 14d
Cleared Jan 02, 1990
MEDI-PACK
K895860
Heatmax Mfg., Inc.
Physical Medicine · 91d
Cleared Sep 05, 1989
STAT-PAD
K894926
Hettel Accessories, Inc.
Physical Medicine · 34d
Cleared Mar 14, 1989
THERMO-PACK
K890924
Medical Manufacturers, Inc.
Physical Medicine · 18d
Cleared Feb 13, 1989
CP&S DISPOSABLE INSTANT COLD COMPRESS
K890553
Consolidated Products & Services, Inc.
Physical Medicine · 7d
Cleared Feb 13, 1989
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
K890554
Consolidated Products & Services, Inc.
Physical Medicine · 7d
Cleared Sep 30, 1988
HARE COLD PACK
K883966
Dyna Industries, Inc.
Physical Medicine · 10d
Cleared May 20, 1988
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
K880871
John Wagner Associates, Inc.
Physical Medicine · 80d