Panels › Physical Medicine › Product code MPO · Class 1
Infant Heel Warmer (Chemical Heat Pack)
Regulation 890.5710
0510(k)s in 12 months (11 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in MPO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 3 |
| CooperSurgical, Inc. | 1 | 1 |
| Covidien LLC | 0 | 2 |
| Rapid Aid , Ltd. | 2 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Debusk Knitting Mills, Div. Deroyal Industries | 1 | 0 |
| Denovo Products, LLC | 1 | 0 |
| Florida Medical Industries, Inc. | 1 | 0 |
| International Biomedical | 1 | 0 |
| Mediheat, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2022 | K221154 | Infant Heel WarmerTM; Heel Snuggler® International Biomedical | MPO |
| Mar 18, 2016 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) CooperSurgical, Inc. | MPO |
| May 27, 2015 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer Rapid Aid Corp., CA | MPO |
| Apr 8, 2011 | K103549 | DENOVO TEDDY GEL INFANT HEEL WARMER Denovo Products, LLC | MPO |
| Sep 19, 2006 | K053254 | INFANT HEEL WARMER BY INTCO Shanghai Intco Medical Supply Co., Ltd. | MPO |
| May 3, 2004 | K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER Rapid Aid , Ltd., CA | MPO |
| Jan 27, 2004 | K040044 | HEEL SNUGGLER, MODEL 99047 Respironics, Inc. | MPO |
| Oct 22, 2003 | K032989 | MEDI-HEAT INFANT HEEL WARMER Mediheat, Inc. | MPO |
| Feb 10, 1997 | K964523 | RECOVER INFANT HEEL WARMER (5100) Florida Medical Industries, Inc. | MPO |
| Jun 6, 1996 | K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER Baxter Healthcare Corp | MPO |
| Jan 11, 1996 | K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER Debusk Knitting Mills, Div. Deroyal Industries | MPO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.