Identity
- Trade Name
- Famidoc FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Pain Relief Plaster FDA UDI
- Model / Reference
- FDES105 FDA UDI
- Description
- Pain Relief Plaster FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854314007503 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Famidoc by Famidoc Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130723 also covers:
- Procare Tens Machine — ARISE MEDICAL LLC
- 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
- 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
- Famidoc Usa, Inc.
Sources (1)
- FDA UDI f95c5da8-c3a0-4c31-a228-0cc25d2d560e 34 fields · synced May 29, 2026