Identity
- Trade Name
- Ibramed FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- Nèartek is a microcontrolled device with Tecarterapia (High Frequency Capacitive and Resistive Electrical Transfer) and Radiofrequency therapies. Both therapies are considered non-invasive therapeutic modalities that use high-frequency electric current through capacitive and/or resistive applicators, have the same physical principles, physiological effects, indications for use and contraindications and can be used in the areas of physical rehabilitation, facial, body and intimate aesthetics. FDA UDI
- Model / Reference
- Neartek FDA UDI
- Description
- Nèartek is a microcontrolled device with Tecarterapia (High Frequency Capacitive and Resistive Electrical Transfer) and Radiofrequency therapies. Both therapies are considered non-invasive therapeutic modalities that use high-frequency electric current through capacitive and/or resistive applicators, have the same physical principles, physiological effects, indications for use and contraindications and can be used in the areas of physical rehabilitation, facial, body and intimate aesthetics. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898966442940 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held electric massager
Ibramed by Ibramed Industria Brasileira de Equipamentos Medicos Eir — Class I — 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 I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI fcea72f5-8db2-4f75-bdf5-6ca82cb163c9 33 fields · synced May 30, 2026