INDIBA DEEP CARE - EVONY IDC0409USA

GUDID 08434251003084

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.

INDIBA SA.

Medium-wave diathermy treatment system

• Primary Device ID: 08434251003084
• NIH Device Record Key: 7ca050d5-73d0-466a-890a-974c0b22c63a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDIBA DEEP CARE - EVONY
• Version Model Number: IDC0409
• Catalog Number: IDC0409USA
• Company DUNS: 460060916
• Company Name: INDIBA SA.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08434251003084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241107

FDA Product Code

• PBX: Massager, vacuum, radio frequency induced heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-14
• Device Publish Date: 2025-02-06

Devices Manufactured by INDIBA SA.

• 08434251003084 - INDIBA DEEP CARE - EVONY: 2025-02-14Radiofrequency 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.
• 08434251003084 - INDIBA DEEP CARE - EVONY: 2025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to
• 08434251003640 - INDIBA ACTIV - ACTIV CT9: 2025-02-14 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Activ CT9 device is intended
• 08434251000229 - INDIBA ACTIV - CT9: 2025-02-07 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories
• 08434251002636 - INDIBA DEEP CARE - REVERSO: 2023-06-13 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 08434251002667 - INDIBA DEEP CARE - REVERSO - Applicator handle: 2023-06-13 Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
• 18434251002640 - INDIBA DEEP CARE - REVERSO - Tip 80 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b
• 18434251002657 - INDIBA DEEP CARE - REVERSO - Tip 160 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b
• 18434251002718 - INDIBA DEEP CARE - REVERSO - Tip 88 pins: 2023-06-13 Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to b