MPO · Infant Heel Warmer (Chemical Heat Pack)
Physical Medicine · 21 CFR 890.5710 · Class 1
Overview
| Product Code | MPO |
|---|---|
| Device Name | Infant Heel Warmer (Chemical Heat Pack) |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
Classification Rationale
Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | Oct 7, 2022 | SESE |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | Mar 18, 2016 | SESE |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | May 27, 2015 | SESE |
| K103549 | DENOVO TEDDY GEL INFANT HEEL WARMER | Denovo Products, LLC | Apr 8, 2011 | SESE |
| K053254 | INFANT HEEL WARMER BY INTCO | Shanghai Intco Medical Supply Co., Ltd. | Sep 19, 2006 | SESE |
| K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | Rapid Aid , Ltd. | May 3, 2004 | SESE |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | Jan 27, 2004 | SESE |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | Oct 22, 2003 | SESE |
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Florida Medical Industries, Inc. | Feb 10, 1997 | SESE |
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Baxter Healthcare Corp | Jun 6, 1996 | SESE |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | Jan 11, 1996 | SESE |
Top Applicants
- Baxter Healthcare Corp — 1 clearance
- CooperSurgical, Inc. — 1 clearance
- Debusk Knitting Mills, Div. Deroyal Industries — 1 clearance
- Denovo Products, LLC — 1 clearance
- Florida Medical Industries, Inc. — 1 clearance
