Identity
- Trade Name
- Famidoc FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，Post traumatic pain，post surgical pain，Relaxation of muscle spasm， Increase blood flow circulation，Prevention or retardation of disuse atrophy， Muscle re-education， Maintaining or increasing range of motion.，Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. FDA UDI
- Model / Reference
- FDES116A FDA UDI
- Description
- The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，Post traumatic pain，post surgical pain，Relaxation of muscle spasm， Increase blood flow circulation，Prevention or retardation of disuse atrophy， Muscle re-education， Maintaining or increasing range of motion.，Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970389630096 FDA UDI
- 510(k) Number
- K113010 FDA UDI
- FDA Product Code
- IPF FDA UDIGZJ FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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
Yes
FDA UDI
Over-the-Counter
No
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: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemTranscutaneous electrical stimulation lead
Famidoc 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
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 94de3766-8a38-41cc-a515-c2bb8a62b2e2 34 fields · synced May 30, 2026