The following data is part of a premarket notification filed by Digital Heat Corporation with the FDA for Heated Eye Pad.
| Device ID | K142228 |
| 510k Number | K142228 |
| Device Name: | Heated Eye Pad |
| Classification | Pad, Heating, Powered |
| Applicant | Digital Heat Corporation 5626 S. Captain Kidd Ct. Unit B Tempe, AZ 85283 |
| Contact | John Devine |
| Correspondent | John Devine Digital Heat Corporation 5626 S. Captain Kidd Ct. Unit B Tempe, AZ 85283 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2015-02-09 |