Infant Transport Mattress Warmer with Disc— 510(k) K163295

Substantially Equivalent

Rapid Aid Corp.

FDA 510(k) clearance K163295 for Infant Transport Mattress Warmer with Disc, Substantially Equivalent on 2017-07-24. Applicant: Rapid Aid Corp..

Clearance details

Applicant: Rapid Aid Corp.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 2016-11-22
Decision date: 2017-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.