The following data is part of a premarket notification filed by Mediheat, Inc. with the FDA for Medi-heat Infant Heel Warmer.
| Device ID | K032989 |
| 510k Number | K032989 |
| Device Name: | MEDI-HEAT INFANT HEEL WARMER |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | MEDIHEAT, INC. 505 HILL ROAD Dalton, GA 30722 |
| Contact | Uma Ramachandran |
| Correspondent | Uma Ramachandran MEDIHEAT, INC. 505 HILL ROAD Dalton, GA 30722 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2003-10-22 |
| Summary: | summary |