MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k) K250356 · Infobionic, Inc.
510(k) numberK250356
Submission
- Device name
- MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- Applicant
- Infobionic, Inc.
Chelmsford, MA, US - Received
- February 7, 2025
- Decision date
- July 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | Medicalgorithmics S.A. | 07/11/2018SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | 10/06/2023SE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated | 03/11/2016SE |
| K152491 | MoMe Software PlatformDSI · Traditional | 12/17/2015SE |
| K133753 | Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional | 09/19/2014SE |
Questions and answers
When was MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) cleared by the FDA?
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) received a 510(k) decision of Substantially Equivalent on July 29, 2025, 172 days after the submission was received.
What is the product code of K250356?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.