IME · Class I · 21 CFR 890.5700

FDA Product Code IME: Pack, Hot Or Cold, Reusable

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

27
Total
27
Cleared
64d
Avg days
1977
Since

FDA 510(k) Cleared Pack, Hot Or Cold, Reusable Devices (Product Code IME)

27 devices
1–24 of 27
Cleared Nov 30, 1988
SUBOCCIPITAL ICE PILLOW
K882413
Ferguson Medical
Physical Medicine · 170d
Cleared Aug 31, 1983
NICE PACK
K832193
Universal Medical Instrument Corp.
Physical Medicine · 54d
Cleared Jan 21, 1983
THERMOELASTOMER HOT/COLD COMPRESS BK7186
K823649
Fred Sammons, Inc.
Physical Medicine · 46d
Cleared Jan 21, 1983
THERMOELASTOMER HOT/COLD COMPRESS-7187-
K823650
Fred Sammons, Inc.
Physical Medicine · 46d
Cleared Jan 14, 1983
HOT/COLD PACK HOLDERS
K823814
Danek Medical, Inc.
Physical Medicine · 28d
Cleared Jun 11, 1982
ATTACH-A-PAK
K821636
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Mar 04, 1981
ACE COLD BANDAGE
K810402
Bd Becton Dickinson Vacutainer Systems Preanalytic
Physical Medicine · 14d
Cleared Mar 04, 1981
REUSEABLE HOT & COLD PACKS
K810451
Fred Sammons, Inc.
Physical Medicine · 13d
Cleared Nov 15, 1979
ICE CONTAINER I.C.E.
K792182
Delta Medical Industries
Physical Medicine · 17d
Cleared Jan 22, 1979
ICE PACK, REUSABLE FLEXIBLE
K790009
Ackrad Laboratories
Physical Medicine · 20d

About Product Code IME - Regulatory Context