Identity
- Trade Name
- COMPACT LITE FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- Radiofrequency device. Electrosurgical cutting and coagulation device and accessories. The INDIBA COMPACT LITE device is a therapeutic device for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes. The electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable. FDA UDI
- Model / Reference
- ACT0507 FDA UDI
- Description
- Radiofrequency device. Electrosurgical cutting and coagulation device and accessories. The INDIBA COMPACT LITE device is a therapeutic device for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes. The electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable. FDA UDI
Identifiers
- Catalog Number
- ACT0507USA FDA UDI
- Primary DI / UDI-DI
- 08434251004791 FDA UDI
- 510(k) Number
- K243164 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
Compact Lite by Indiba Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medium-wave diathermy treatment system.
- Wonder Touch — XOD Inc · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
- Human Tecar — UNIBELL SRL · Class II
Cleared under the same submission
K243164 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Indiba Sa.
Sources (1)
- FDA UDI d55c7448-3840-4b3b-8654-0ce2bf0db633 35 fields · synced May 30, 2026