Identity
- Trade Name
- Well at Walgreens FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- 2.08" X 2.87" gel electrodes body pads FDA UDI
- Model / Reference
- FDES105B Body Pads (P105B-2) FDA UDI
- Description
- 2.08" X 2.87" gel electrodes body pads FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917176406 FDA UDI
- 510(k) Number
- K130723 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 5.97 Square inch 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
Similar devices
Also classified as Analgesic transcutaneous electrical nerve stimulation system.
- AVCOO — ADP HEALTH LIMITED · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- HTG Life — FRAMEWERK LLC · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- 1byone — 1BYONEPRODUCTS INC. · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- COMPEX — DJO, LLC · Class II
Cleared under the same submission
K130723 also covers:
- Procare Tens Machine — ARISE MEDICAL LLC
- Famidoc — FAMIDOC USA, INC.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI 56f7184a-d8e2-473c-8771-6d7b30a0851e 37 fields · synced Jun 6, 2026