S-Patch (S-Patch ExL)
FDA 510(k) clearance K233906 · decided 2024-02-16
Clearance details
- K-number
- K233906
- Device name
- S-Patch (S-Patch ExL)
- Applicant
- Wellysis Corp.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-12
- Decision date
- 2024-02-16
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- DSH
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LifeLens Physiological Monitor (K260157) | LifeLens Technologies, Inc. | 2026-07-09 |
| Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (K252389) | Smwmed, Inc. | 2026-04-23 |
| VitaloJAK Clinic (Model 7100) (K253293) | Vitalograph , Ltd. | 2025-12-03 |
| Zio® monitor (DFG0001) (K243650) | iRhythm Technologies, Inc. | 2025-08-15 |
| AeviceMD (K243603) | Aevice Health Pte. , Ltd. | 2025-05-05 |
| AT-Patch (ATP-C130/ATP-C70) (K242583) | Atsens Co., Ltd. | 2025-05-02 |
| HiCardi+ H100 (K232670) | MEZOO Co., Ltd. | 2024-09-20 |
| ABPMpro (K231104) | Somnomedics GmbH | 2023-11-27 |
| Carnation Ambulatory Monitor (K233110) | Bardy Diagnostics, Inc. | 2023-11-22 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| S-Patch Ex Wearable ECG Patch (K231289) | Wellysis Corp. | 2023-08-30 |
| AeviceMD (K223382) | Aevice Health Pte. , Ltd. | 2023-07-07 |
Recalls involving this device
No recalls on record reference this clearance.