Clearance Summary
Rapid Aid Instant Disposable Infant Heel Warmer received FDA 510(k) clearance under submission number K150627, sponsored by Rapid Aid Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2015-05-27.
- Submission: K150627
- Applicant / Sponsor: Rapid Aid Corp.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 2015-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MPO and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.