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PocketECG IV – Unified Arrhythmia Diagnostic System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PocketECG IV – Unified Arrhythmia Diagnostic System FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks. FDA UDI
- Model / Reference
- P4TR-AB-ADS FDA UDI
- Description
- The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05903021560087 FDA UDI
- 510(k) Number
- K193104 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiography telemetric monitoring system
PocketECG IV – Unified Arrhythmia Diagnostic System by Medicalgorithmics S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193104 also covers:
- Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medicalgorithmics S.A.
Sources (1)
- FDA UDI 07ad370a-e4c5-4782-9934-070b8542e1a5 34 fields · synced May 30, 2026