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 Consolidated Products & Services, Inc..

82
Total
82
Cleared
75d
Avg days
1976
Since
82 devices
49–72 of 82
Cleared Nov 17, 1987
HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
K873364
Hypertherm Technologies, Inc.
Physical Medicine · 88d
Cleared Apr 06, 1987
INSTANT COLD COMPRESS, CHEMICAL TYPE
K871168
Lexington Industries
Physical Medicine · 13d
Cleared Mar 25, 1987
INSTANT HEAT COMPRESS, CHEMICAL TYPE
K871114
Lexington Industries
Physical Medicine · 6d
Cleared Mar 12, 1987
OXY-THERM
K870832
M.D. Intl., Inc.
Physical Medicine · 9d
Cleared Sep 19, 1986
PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS
K863507
Physician & Nurses Mfg. Corp.
Physical Medicine · 10d
Cleared Feb 27, 1986
MAZING HEAT DISPOSABLE WARM PACK
K860444
Leebryan Intl.
Physical Medicine · 23d
Cleared Sep 25, 1985
HOT OR HEAT PACK
K853148
Matrix Intl.
Physical Medicine · 58d
Cleared Sep 06, 1985
ALLY PORTABLE NOT PACK/PAD DISPOSABLE
K853045
Actin International, Inc.
Physical Medicine · 49d
Cleared Aug 12, 1985
HOT PACK
K852610
Oriental Medical Supplies, Inc.
Physical Medicine · 54d
Cleared May 29, 1985
MARUKYR-BAN / HOT OR HEAT PACK
K850566
Oriental Medical Supplies, Inc.
Physical Medicine · 106d
Cleared Apr 25, 1985
EXOTHERMIC HEATING PAD
K850637
Travenol Laboratories, S.A.
Physical Medicine · 65d
Cleared Nov 23, 1984
EIXO THERMUS HEATING PADS
K844224
Eixo Thermus
Physical Medicine · 22d
Cleared May 13, 1982
SPENCO CRYOPRESS
K820906
Spenco Medical Corp.
Physical Medicine · 42d
Cleared Apr 29, 1982
COMPRES PORTABLE HEAT PADS
K821046
S.C. Johnson & Son, Inc.
Physical Medicine · 15d
Cleared Mar 08, 1982
HOT MINI 15 & HOT MINI 24
K820359
Hot Mini International, Inc.
Physical Medicine · 27d
Cleared Feb 12, 1982
ACE BRAND INSTANT COLD PACK
K820282
Bd Becton Dickinson Vacutainer Systems Preanalytic
Physical Medicine · 10d
Cleared Jan 19, 1982
BK-7182 INSTANT COLD PACK
K813628
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jul 31, 1981
JAPANESE HOTZIE
K811803
Consolidated Health & Sports Prod.
Physical Medicine · 37d
Cleared May 21, 1981
SELF HEATING DISPOSABLE HEAT PAD
K811206
Ensar Corp.
Physical Medicine · 20d
Cleared Mar 26, 1981
WONDER WARMER
K810633
Montvale Products, Inc.
Physical Medicine · 16d
Cleared Mar 26, 1981
CURITY PERINEAL WARM PACK
K810692
The Kendal Co.
Physical Medicine · 13d
Cleared Mar 26, 1981
CURITY PERINEAL COLD PACK
K810693
The Kendal Co.
Physical Medicine · 13d
Cleared Oct 03, 1980
HOT CYCLE, A CHEMICAL TYPE HOT PACK
K802252
Signal West
Physical Medicine · 17d
Cleared Sep 07, 1979
INSTANT HOT & COLD PACKS
K790993
Chase Mfg. Co.
Physical Medicine · 101d