Clearance Summary
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER received FDA 510(k) clearance under submission number K040856, sponsored by Rapid Aid , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2004-05-03.
- Submission: K040856
- Applicant / Sponsor: Rapid Aid , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 2004-05-03
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.