510(k) K142228
K142228 is an FDA 510(k) premarket notification submitted by Digital Heat Corporation for the device "Heated Eye Pad". The FDA issued a decision of Substantially Equivalent on February 9, 2015. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2015
- Date Received
- August 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Heating, Powered
- Device Class
- Class II
- Regulation Number
- 890.5740
- Review Panel
- PM
- Submission Type