Product code IMD
- Device name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5710
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 |
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Candela Laser Corp. | 1996-08-15 |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | 1996-05-06 |
| K954877 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-02-13 |
| K953442 | RESTORE, THERMACELLS (HOT PACK I) | Neal Dunning Assoc., Inc. | 1995-10-31 |
| K953542 | COLDGEL | Prism Technologies, Inc. | 1995-10-30 |
| K953541 | INSTANT COLDGEL | Prism Technologies, Inc. | 1995-10-05 |
| K950680 | INFANT HEEL WARMER | Baxter Healthcare Corp | 1995-08-23 |
| K951383 | TEMPRA HEAT PACK | Tempra Technology, Inc. | 1995-06-01 |
| K941245 | POLY-MEDICS HEAT PACK | Biomet, Inc. | 1994-05-02 |
| K936084 | OMNI WARM GEL PACKS | Omni Therm, Inc. | 1994-03-31 |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | Certified Safety Mfg., Inc. | 1994-03-07 |
| K935569 | INSTANT HOT OR COLD DISPOSABLE PACK | Cryopak Industries, Inc. | 1994-03-07 |
| K934631 | TRANSWARMER | Prism Technologies, Inc. | 1994-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00049696562102 | B.PURE | FOURSTAR GROUP INC. | 2026-06-09 |
| 00049696561518 | B.PURE | FOURSTAR GROUP INC. | 2026-06-09 |
| 08436587170522 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-18 |
| 08436587170577 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587171031 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587171017 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170973 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170966 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170942 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170867 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170843 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170812 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170638 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170560 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170553 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170386 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170362 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170249 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170232 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170225 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170102 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170065 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170027 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587170010 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-15 |
| 08436587171062 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-14 |
| 08436587171079 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-14 |
| 08436587171086 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-14 |
| 08436587171109 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-14 |
| 08436587171116 | ANF Therapy® | AMINO FREQUENCY CORPORATION SL. | 2026-05-14 |
| 00192253061140 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-03-06 |