FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPACT LITE
DI: 08434251004791
·
Model: ACT0507
·
INDIBA SA.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMPACT LITE
- Primary DI
- 08434251004791
- Version / Model
- ACT0507
- Catalog Number
- ACT0507USA
- Company Name
- INDIBA SA.
- Labeler DUNS
- 460060916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-29
- Public Version
- 1
- Public Version Date
- 2025-02-06
- Public Version Status
- New
- Public Device Record Key
- d55c7448-3840-4b3b-8654-0ce2bf0db633
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47575 | Medium-wave diathermy treatment system | An assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The system is commonly used in outpatient, rehabilitation, traumatology, and sports centre settings to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08434251004791 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243164 | 000 |