Panels › Physical Medicine › Product code IME · Class 1
Pack, Hot Or Cold, Reusable
Regulation 890.5700
0510(k)s in 12 months (27 all time)
1recalls in 12 months (12 all time)
0recalls that name a 510(k)
Top companies in IME
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 8 |
| Fred Sammons, Inc. | 4 | 0 |
| Ackrad Laboratories | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Danek Medical, Inc. | 1 | 0 |
| Delta Medical Industries | 1 | 0 |
| DJO, LLC | 0 | 1 |
| Dr. Micheal A. Sabia | 1 | 0 |
| Ferguson Medical | 1 | 0 |
| Friendmed Products | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 1993 | K923627 | COLD PACK Friendmed Products | IME |
| Feb 12, 1993 | K915876 | HOTPAD Ten Comfort Corp., CN | IME |
| Jul 13, 1992 | K921446 | HOT OR COLD PACK (THERMIPAQ) Thermionics Corp. | IME |
| Jan 22, 1991 | K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS Micro Surgical Instruments Corp. | IME |
| Nov 30, 1988 | K882413 | SUBOCCIPITAL ICE PILLOW Ferguson Medical | IME |
| Oct 23, 1986 | K863654 | RE-HEATER, HOT PACK K & L Ent. | IME |
| Aug 31, 1983 | K832193 | NICE PACK Universal Medical Instrument Corp. | IME |
| Jul 7, 1983 | K831899 | ENSWELL Dr. Micheal A. Sabia | IME |
| Jun 3, 1983 | K830981 | MICROPAK MOIST HEAT PAD Micropak Manufacturers, Inc. | IME |
| Mar 10, 1983 | K830416 | ICY COLD ICE CAP Ladora Ent. | IME |
| Jan 21, 1983 | K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- Fred Sammons, Inc. | IME |
| Jan 21, 1983 | K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 Fred Sammons, Inc. | IME |
| Jan 14, 1983 | K823814 | HOT/COLD PACK HOLDERS Danek Medical, Inc. | IME |
| Oct 6, 1982 | K822783 | FLEX ICE FREEZE PACK Igloo Corp. | IME |
| Jun 11, 1982 | K821636 | ATTACH-A-PAK Fred Sammons, Inc. | IME |
| Apr 15, 1982 | K820901 | COLD ROLL North Bank Labs, Inc. | IME |
| Jan 28, 1982 | K820068 | COLD-HOT PACK Hospital Marketing Services Co., Inc. | IME |
| Mar 4, 1981 | K810451 | REUSEABLE HOT & COLD PACKS Fred Sammons, Inc. | IME |
| Mar 4, 1981 | K810402 | ACE COLD BANDAGE Bd Becton Dickinson Vacutainer Systems Preanalytic | IME |
| Jan 15, 1981 | K803299 | COLD/HOT PACK W.G. Whitney Corp. | IME |
| Aug 7, 1980 | K801776 | COLD PACK #589 Sunbeam Corp. | IME |
| Aug 7, 1980 | K801365 | KOLD WRAP Romaine, Inc. | IME |
| May 2, 1980 | K800917 | TRU-COLD THERAPY PAK Tru-Eze Mfg. Co., Inc. | IME |
| Nov 15, 1979 | K792182 | ICE CONTAINER I.C.E. Delta Medical Industries | IME |
| Oct 30, 1979 | K791684 | WARM-EE HEAT PACK U.S. Export Marketing Group, Inc. | IME |
| Jan 22, 1979 | K790009 | ICE PACK, REUSABLE FLEXIBLE Ackrad Laboratories | IME |
| Aug 30, 1977 | K771002 | ICE BAND Norcliff Thayer, Inc. | IME |
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