Identity
- Trade Name
- GLOBUS FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- The Diacare is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. T FDA UDI
- Model / Reference
- DIACARE 5500 PRO FDA UDI
- Description
- The Diacare is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. T FDA UDI
Identifiers
- Catalog Number
- G6457 FDA UDI
- Primary DI / UDI-DI
- 08032625821137 FDA UDI
- 510(k) Number
- K211207 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Medium-wave diathermy treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medium-wave diathermy treatment system
Globus by Domino Srl — 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
- Domino Srl
Sources (1)
- FDA UDI 477b7286-3401-43df-8c06-6ba1814663c6 35 fields · synced May 31, 2026