Identity
- Trade Name
- Easy@Home TENS Pain Relief Device FDA UDI
- Generic Name
- Static magnetic therapeutic clothing/jewelry FDA UDI
- Model / Reference
- EHE009 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810038630113 FDA UDI
- 510(k) Number
- K131921 FDA UDI
- FDA Product Code
- NUH FDA UDI
- GMDN Term
- Static magnetic therapeutic clothing/jewelry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Static magnetic therapeutic clothing/jewelry
Easy@Home TENS Pain Relief Device by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Static magnetic therapeutic clothing/jewelry.
- Pulse Massager — BETTER BASICS, INC. · Class II
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- Active Health Labs TENS Electronic Pulse Massager — DEAL NOVA LLC · Class II
- Pulse Massager — BETTER BASICS, INC. · Class II
- Easy@Home Mini Wireless TENS Pulse Stimulator — EASY HEALTHCARE CORPORATION · Class II
- Easy@Home Electronic TENS Pulse Massager — EASY HEALTHCARE CORPORATION · Class II
- Easy@Home Mini Electronic Pulse Stimulator — EASY HEALTHCARE CORPORATION · Class II
Cleared under the same submission
K131921 also covers:
- Pulse Massager — BETTER BASICS, INC.
- Easy@Home Electronic TENS Pulse Massager — EASY HEALTHCARE CORPORATION
- Easy@Home Electronic TENS Pulse Massager — EASY HEALTHCARE CORPORATION
- Easy@Home Electronic TENS Pulse Massager — EASY HEALTHCARE CORPORATION
- Easy@Home TENS Pain Relief Device — EASY HEALTHCARE CORPORATION
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 1630d523-944d-4f49-9ec0-91454ebfc722 33 fields · synced May 30, 2026