Submission Details
| 510(k) Number | K150627 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 11, 2015 |
| Decision Date | May 27, 2015 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Special
Rapid Aid Instant Disposable Infant Heel Warmer
May 2015
Decision
77d
Days
Class 1
Risk
About This 510(k) Submission
K150627 is an FDA 510(k) clearance for the Rapid Aid Instant Disposable Infant Heel Warmer, a Infant Heel Warmer (chemical Heat Pack) (Class I — General Controls, product code MPO), submitted by Rapid Aid Corp. (Mississauga, CA). The FDA issued a Cleared decision on May 27, 2015, 77 days after receiving the submission on March 11, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.
Device Classification
| Product Code | MPO — Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5710 |
Manufacturer
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