Identity
- Trade Name
- Well at Walgreens FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- 1 Tens control unit with 1 pc of 53 mm x 73 mm pad, 1pc of 190 mm X 95 mm pad & battery . FDA UDI
- Model / Reference
- FDES105B FDA UDI
- Description
- 1 Tens control unit with 1 pc of 53 mm x 73 mm pad, 1pc of 190 mm X 95 mm pad & battery . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917176383 FDA UDI
- 510(k) Number
- K130723 FDA UDI
- FDA Product Code
- NUH FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system 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
Yes
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Well at Walgreens by Walgreen Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130723 also covers:
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- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- HOMEDICS — FKA DISTRIBUTING CO., LLC
- HOMEDICS — FKA DISTRIBUTING CO., LLC
- Belifu — Famidoc Technology Company Limited
- EQUATE — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Mothermed — Famidoc Technology Company Limited
- Mothermed — Famidoc Technology Company Limited
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
- Walgreen Co.
Sources (1)
- FDA UDI 34a5ac25-8cd4-4b5c-bcbf-82a67f84e73a 36 fields · synced Jun 8, 2026