Identity
- Trade Name
- Mothermed FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- 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
- ES408 FDA UDI
- Description
- 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
- 00818218024080 FDA UDI
- 510(k) Number
- K130723 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDIGXY FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 FDA UDI882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation lead
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
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 c3a8f455-8f18-4d85-97df-9174a266dbf3 34 fields · synced May 30, 2026