Heated Eye Pad— 510(k) K142228
Substantially EquivalentDigital Heat Corporation
FDA 510(k) clearance K142228 for Heated Eye Pad, Substantially Equivalent on 2015-02-09. Applicant: Digital Heat Corporation.
Clearance details
- Applicant
- Digital Heat Corporation
- Product code
- Code IRT
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Adverse events under product code IRT
product code IRT- Injury
- 668
- Total
- 668
Source: openFDA MAUDE database, through . 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.