Identity
- Trade Name
- SimulCareII FDA UDI
- Generic Name
- Transcutaneous electrical stimulation probe FDA UDI
- Device Name
- The SimluCare II Multifunction Therapeutic Device is intended for the temporary relieve of minor muscle and joint pain, promoting the relaxation of muscle tissues, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain. FDA UDI
- Model / Reference
- SimulCareII FDA UDI
- Description
- The SimluCare II Multifunction Therapeutic Device is intended for the temporary relieve of minor muscle and joint pain, promoting the relaxation of muscle tissues, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B495SIMULCAREII0 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation probe 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation probe
SimulCareII by Xanacare Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Xanacare Technologies, LLC
Sources (1)
- FDA UDI 6f363575-4610-4c7e-96ed-5e7ba42fe308 33 fields · synced May 31, 2026