FDA 510(k) Applications for Medical Device Product Code "IMD"
(Pack, Hot Or Cold, Disposable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973770 | ALLEGIANCE HEALTHCARE CORP. | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | 11/13/1997 |
| K982652 | ALLEGIANCE HEALTHCARE CORP. | ALLEGIANCE PORTA-WARM MATTRESS | 01/21/1999 |
| K970399 | ALLEGIANCE HEALTHCARE CORP. | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | 04/03/1997 |
| K021843 | BIO-LIPID, INC. | EYEFEEL OPHTHALMIC WARMER | 09/03/2002 |
| K082087 | BIO-LIPID, INC. | EYEFEEL OPHTHALMIC WARMER | 09/11/2008 |
| K951033 | CANDELA LASER CORP. | ANDELA DYNAMIC COOLING DEVICE | 08/15/1996 |
| K960624 | CERTIFIED SAFETY MFG., INC. | CERTI COOL INSTANT COLD COMPRESS | 05/06/1996 |
| K974190 | CONSOLIDATED PRODUCTS & SERVICES, INC. | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | 11/19/1997 |
| K112547 | DENOVO PROUCTS LLC | NEO NEST | 03/06/2012 |
| K980509 | DEROYAL INDUSTRIES, INC. | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | 02/26/1998 |
| K963689 | FLORIDA MEDICAL INDUSTRIES, INC. | RECOVER ADULT VEIN WARMER | 12/12/1996 |
| K221653 | International Biomedical | InfaTherm Disposable Infant Warming Mattress | 10/06/2022 |
| K071710 | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | 08/14/2007 |
| K963666 | KICK ICE, INC. | INSTANT COLD PACK | 10/30/1996 |
| K963768 | KICK ICE, INC. | INSTANT HOT PACKS | 11/25/1996 |
| K955788 | OMNI THERM, INC. | IMNI HOT PACKS | 09/04/1996 |
| K954877 | OMNI THERM, INC. | OMNI COLD GEL PACKS | 02/13/1996 |
| K961176 | OMNI THERM, INC. | OMNI COLD GEL PACKS | 09/04/1996 |
| K163295 | RAPID AID CORP. | Infant Transport Mattress Warmer with Disc | 07/24/2017 |
| K963220 | TEMPO TECHNOLOGY, INC. | TEMPRA COLD PACK, REORDER NO. TC150 | 10/10/1996 |
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