Identity
- Trade Name
- INDIBA DEEP CARE - EVONY FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions. FDA UDI
- Model / Reference
- IDC0409 FDA UDI
- Description
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions. FDA UDI
Identifiers
- Catalog Number
- IDC0409USA FDA UDI
- Primary DI / UDI-DI
- 08434251003084 FDA UDI
- 510(k) Number
- K241107 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
Yes
FDA UDI
Category: Medium-wave diathermy treatment system
Indiba Deep Care - Evony by Indiba Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K241107 also covers:
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
- Indiba Sa.
Sources (1)
- FDA UDI 7ca050d5-73d0-466a-890a-974c0b22c63a 35 fields · synced Jun 1, 2026