Identity
- Trade Name
- Mothermed FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- The product is suitable to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. FDA UDI
- Model / Reference
- ES405 FDA UDI
- Description
- The product is suitable to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818218024059 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
Mothermed by Famidoc Technology Company Limited — 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.
- 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
- Famidoc Technology Company Limited
Sources (1)
- FDA UDI 3d599f28-4d5f-4afe-b408-32313389ee55 34 fields · synced Jun 8, 2026