FDA 510(k) Applications for Medical Device Product Code "MPO"
(Infant Heel Warmer (Chemical Heat Pack))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961154 | BAXTER HEALTHCARE CORP. | BAXTER SODIUM ACETATE INFANT HEEL WARMER | 06/06/1996 |
| K151845 | COOPERSURGICAL, INC. | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | 03/18/2016 |
| K954716 | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES | DEROYAL INDUSTRIES INFANT HEEL WARMER | 01/11/1996 |
| K103549 | DENOVO PRODUCTS LLC | DENOVO TEDDY GEL INFANT HEEL WARMER | 04/08/2011 |
| K964523 | FLORIDA MEDICAL INDUSTRIES, INC. | RECOVER INFANT HEEL WARMER (5100) | 02/10/1997 |
| K221154 | International Biomedical | Infant Heel WarmerTM; Heel Snuggler« | 10/07/2022 |
| K032989 | MEDIHEAT, INC. | MEDI-HEAT INFANT HEEL WARMER | 10/22/2003 |
| K150627 | RAPID AID CORP. | Rapid Aid Instant Disposable Infant Heel Warmer | 05/27/2015 |
| K040856 | RAPID AID LTD. | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | 05/03/2004 |
| K040044 | RESPIRONICS, INC. | HEEL SNUGGLER, MODEL 99047 | 01/27/2004 |
| K053254 | SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. | INFANT HEEL WARMER BY INTCO | 09/19/2006 |
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