Identity
- Trade Name
- Emay FDA UDI
- Generic Name
- Electrocardiographic monitor FDA UDI
- Device Name
- It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot. FDA UDI
- Model / Reference
- EMG-20 FDA UDI
- Description
- It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897087200203 FDA UDI
- 510(k) Number
- K152863 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiographic monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic monitor
Emay by Emay (hk) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic monitor.
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- Matrix Mini ECG Module Kit — GLOBAL INSTRUMENTATION, LLC · Class II
- Kardia Mobile — AliveCor · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Patient Cable — GLOBAL INSTRUMENTATION, LLC · Class II
- HeartCheck Palm — CardioComm Solutions, Inc · Class II
Cleared under the same submission
K152863 also covers:
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
- Emay (hk) Limited
Sources (1)
- FDA UDI 5118e57d-fd55-4141-a027-0c31996d3330 35 fields · synced Jun 6, 2026