510(k) K254255
K254255 is an FDA 510(k) premarket notification submitted by Wellysis Corp. for the device "S-Patch CardioAI". The FDA issued a decision of Substantially Equivalent on Sep 25, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Wellysis Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2026
- Date Received
- Dec 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)