Product code IME
- Device name
- Pack, Hot Or Cold, Reusable
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5700
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923627 | COLD PACK | Friendmed Products | 1993-04-14 |
| K915876 | HOTPAD | Ten Comfort Corp. | 1993-02-12 |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | 1992-07-13 |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Micro Surgical Instruments Corp. | 1991-01-22 |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | 1988-11-30 |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | 1986-10-23 |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | 1983-08-31 |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | 1983-07-07 |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | 1983-06-03 |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | 1983-03-10 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | 1983-01-14 |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | 1982-10-06 |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | 1982-06-11 |
| K820901 | COLD ROLL | North Bank Labs, Inc. | 1982-04-15 |
| K820068 | COLD-HOT PACK | Hospital Marketing Services Co., Inc. | 1982-01-28 |
| K810451 | REUSEABLE HOT & COLD PACKS | Fred Sammons, Inc. | 1981-03-04 |
| K810402 | ACE COLD BANDAGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-03-04 |
| K803299 | COLD/HOT PACK | W.G. Whitney Corp. | 1981-01-15 |
| K801776 | COLD PACK #589 | Sunbeam Corp. | 1980-08-07 |
| K801365 | KOLD WRAP | Romaine, Inc. | 1980-08-07 |
| K800917 | TRU-COLD THERAPY PAK | Tru-Eze Mfg. Co., Inc. | 1980-05-02 |
| K792182 | ICE CONTAINER I.C.E. | Delta Medical Industries | 1979-11-15 |
| K791684 | WARM-EE HEAT PACK | U.S. Export Marketing Group, Inc. | 1979-10-30 |
| K790009 | ICE PACK, REUSABLE FLEXIBLE | Ackrad Laboratories | 1979-01-22 |
| K771002 | ICE BAND | Norcliff Thayer, Inc. | 1977-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30707387043996 | 3M™ | 3M COMPANY | 2026-04-21 |
| 30707387043989 | 3M™ | 3M COMPANY | 2026-04-21 |
| 10735282287845 | Munchkin | MUNCHKIN, INC. | 2026-03-18 |
| 10885632413797 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-11 |
| 10885632413919 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-04 |
| 10885632413902 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-04 |
| 10885632413896 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-04 |
| 07798094549392 | PROFIT | PANTYMED S.A. | 2024-01-04 |
| 07798094549408 | PROFIT | PANTYMED S.A. | 2024-01-04 |
| 07798094549415 | PROFIT | PANTYMED S.A. | 2024-01-04 |
| 00072239321300 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239321294 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239323878 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239323885 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239323892 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239324813 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239325087 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 10850046230254 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 10850046230278 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 10850046230261 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 10850046230247 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 10885632136726 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-30 |
| 10884527022267 | Uni-Patch | Cardinal Health, Inc. | 2018-06-30 |
| 10884527022410 | Uni-Patch | Cardinal Health, Inc. | 2018-06-30 |
| 10884527022434 | Uni-Patch | Cardinal Health, Inc. | 2018-06-30 |
| 10884527021376 | Uni-Patch | Cardinal Health, Inc. | 2018-06-30 |
| 10884521162082 | Uni-Patch | Cardinal Health, Inc. | 2018-06-30 |
| 10884527022441 | Uni-Patch | Cardinal Health, Inc. | 2018-06-27 |
| 10884527022250 | Uni-Patch | Cardinal Health, Inc. | 2018-06-27 |
| 10884527022427 | Uni-Patch | Cardinal Health, Inc. | 2016-09-24 |