Identity
- Trade Name
- WELL-LIFE FDA UDI
- Generic Name
- Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
- Device Name
- ● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device. FDA UDI
- Model / Reference
- WL-2407 FDA UDI
- Description
- ● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872264071 FDA UDI
- 510(k) Number
- K063660 FDA UDI
- FDA Product Code
- LIH FDA UDI
- GMDN Term
- Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Well-Life by Well-Life Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K063660 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
- Well-Life Healthcare, Inc.
Sources (1)
- FDA UDI 482d05dd-3755-4354-99ca-0f5953b88e5e 35 fields · synced Jun 1, 2026