FDA Product Code
FDA Product Code MPO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5710
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022-10-07 | Traditional | PDF ↗ |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015-05-27 | Special | PDF ↗ |
| K103549 | DENOVO TEDDY GEL INFANT HEEL WARMER | Denovo Products, LLC | 2011-04-08 | Traditional | PDF ↗ |
| K053254 | INFANT HEEL WARMER BY INTCO | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 | Traditional | PDF ↗ |
| K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | Rapid Aid , Ltd. | 2004-05-03 | Traditional | PDF ↗ |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | 2004-01-27 | Traditional | PDF ↗ |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | 2003-10-22 | Traditional | PDF ↗ |
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Florida Medical Industries, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Baxter Healthcare Corp | 1996-06-06 | Traditional | PDF ↗ |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 | Traditional | PDF ↗ |
Product code MPO · Class I · Physical Medicine. Data: openFDA.