Identity
- Trade Name
- ASSURE Wearable ECG FDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- A wearable cardiac episode recorder FDA UDI
- Model / Reference
- 80553-001 FDA UDI
- Description
- A wearable cardiac episode recorder FDA UDI
Identifiers
- Catalog Number
- 80553-001 FDA UDI
- Primary DI / UDI-DI
- 00840241600313 FDA UDI
- 510(k) Number
- K233864 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiograph, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
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
Category: Electrocardiograph, home-use
ASSURE Wearable ECG by Kestra Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiograph, home-use.
- Withings® — Withings SA · Class II
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- AfibAlert / hom ecg+ — LOHMAN TECHNOLOGIES, LLC · Class II
- QT ECG — QT Medical, Inc. · Class II
- GEMS Mobile ECG — CardioComm Solutions, Inc · Class II
- TelePatch Cardiac Monitor — MEDICOMP, INC. · Class II
- KardiaMobile Card — AliveCor · Class II
- Coala Heart Monitor US Rx — Coala-Life AB · Class II
Cleared under the same submission
K233864 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
- Kestra Medical Technologies, Inc.
Sources (1)
- FDA UDI 0dbf56d5-3427-433c-affe-196715ace4da 37 fields · synced Jun 9, 2026