The following data is part of a premarket notification filed by Rapid Aid Corp. with the FDA for Rapid Aid Instant Disposable Infant Heel Warmer.
| Device ID | K150627 |
| 510k Number | K150627 |
| Device Name: | Rapid Aid Instant Disposable Infant Heel Warmer |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | RAPID AID CORP. 4120 A SLADEVIEW CRESENT Mississauga, CA L5l 5z3 |
| Contact | Rose Ren |
| Correspondent | Diane Horwitz MANDELL HORWITZ CONSULTANTS LLC 2995 STEVEN MARTIN DR Fairfax, VA 22031 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-05-27 |
| Summary: | summary |