DEVICE: INDIBA ACTIV - ACTIV CT9 (08434251003640)

Device Identifier (DI) Information

INDIBA ACTIV - ACTIV CT9
ACT0309
In Commercial Distribution
ACT0309BLKUSA
INDIBA SA.
08434251003640
GS1

1
460060916 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
PBX Massager, vacuum, radio frequency induced heat
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K241107 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

173ed5cb-89e2-454b-8c82-78fa40eccfd9
February 14, 2025
1
February 06, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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