Identity
- Trade Name
- Easy@Home Mini Wireless TENS Pulse Stimulator FDA UDI
- Generic Name
- Static magnetic therapeutic clothing/jewelry FDA UDI
- Model / Reference
- EHE015B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810038633350 FDA UDI
- 510(k) Number
- K143268 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- GMDN Term
- Static magnetic therapeutic clothing/jewelry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 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
Yes
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: Static magnetic therapeutic clothing/jewelry
Easy@Home Mini Wireless TENS Pulse Stimulator 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.
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- Pulse Massager — BETTER BASICS, INC. · Class II
- Easy@Home Mini Wireless TENS Pulse Stimulator — EASY HEALTHCARE CORPORATION · Class II
- Easy@Home TENS Pain Relief Device — EASY HEALTHCARE CORPORATION · Class II
- Easy@Home Electronic TENS Pulse Massager — EASY HEALTHCARE CORPORATION · Class II
Cleared under the same submission
K143268 also covers:
- Easy@Home Mini Electronic Pulse Stimulator — EASY HEALTHCARE CORPORATION
- Easy@Home Mini Electronic Pulse Stimulator — EASY HEALTHCARE CORPORATION
- Easy@Home TENS AND MUSCLE STIMULATOR — EASY HEALTHCARE CORPORATION
- Easy@Home TENS and Powered Muscle Stimulator — EASY HEALTHCARE CORPORATION
- MEDVICE — GURIN PRODUCTS LLC
- Utopia Gear — MIDWESTERN SOLUTIONS
- Utopia Gear — MIDWESTERN SOLUTIONS
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
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 5ad02fa6-9f89-4c68-afab-539b0d9f0992 33 fields · synced May 30, 2026