MPO — Infant Heel Warmer (Chemical Heat Pack) Class I
FDA Device Classification
Classification Details
- Product Code
- MPO
- Device Class
- Class I
- Regulation Number
- 890.5710
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K221154 | international biomedical | Infant Heel WarmerTM; Heel Snuggler® | October 7, 2022 |
| K151845 | coopersurgical | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | March 18, 2016 |
| K150627 | rapid aid | Rapid Aid Instant Disposable Infant Heel Warmer | May 27, 2015 |
| K103549 | denovo products | DENOVO TEDDY GEL INFANT HEEL WARMER | April 8, 2011 |
| K053254 | shanghai intco medical supply co | INFANT HEEL WARMER BY INTCO | September 19, 2006 |
| K040856 | rapid aid | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | May 3, 2004 |
| K040044 | respironics | HEEL SNUGGLER, MODEL 99047 | January 27, 2004 |
| K032989 | mediheat | MEDI-HEAT INFANT HEEL WARMER | October 22, 2003 |
| K964523 | florida medical industries | RECOVER INFANT HEEL WARMER (5100) | February 10, 1997 |
| K961154 | baxter healthcare | BAXTER SODIUM ACETATE INFANT HEEL WARMER | June 6, 1996 |
| K954716 | debusk knitting mills, div. deroyal industries | DEROYAL INDUSTRIES INFANT HEEL WARMER | January 11, 1996 |