K053254 is an FDA 510(k) clearance for the INFANT HEEL WARMER BY INTCO. This device is classified as a Infant Heel Warmer (chemical Heat Pack) (Class I - General Controls, product code MPO).
Submitted by Shanghai Intco Medical Supply Co., Ltd. (Chino, US). The FDA issued a Cleared decision on September 19, 2006, 302 days after receiving the submission on November 21, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K053254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2005 |
| Decision Date | September 19, 2006 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MPO — Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |