DEVICE: INDIBA ACTIV - ACTIV CT9 (08434251003640)
Device Identifier (DI) Information
INDIBA ACTIV - ACTIV CT9
ACT0309
In Commercial Distribution
ACT0309BLKUSA
INDIBA SA.
ACT0309
In Commercial Distribution
ACT0309BLKUSA
INDIBA SA.
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
The Indiba Activ CT9 device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PBX | Massager, vacuum, radio frequency induced heat |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K241107 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
173ed5cb-89e2-454b-8c82-78fa40eccfd9
February 14, 2025
1
February 06, 2025
February 14, 2025
1
February 06, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined