Identity
- Trade Name
- Easy@Home Heat TENS unit with Replacement Pads FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Model / Reference
- ETP018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810038631547 FDA UDI
- 510(k) Number
- K200561 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Electric pad localized-body heating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric pad localized-body heating system
Easy@Home Heat TENS unit with Replacement Pads by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200561 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
- Easy Healthcare Corporation
Sources (1)
- FDA UDI d63ae50b-a010-4153-940f-cd692dcb6abf 33 fields · synced May 30, 2026