INDIBA ACTIV - AT7 AT7

GUDID 08434251000915

Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories

INDIBA SA.

Medium-wave diathermy treatment system

• Primary Device ID: 08434251000915
• NIH Device Record Key: 13814fcd-bd36-4c28-83c7-aafdfe0abe88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDIBA ACTIV - AT7
• Version Model Number: ACT0407USA
• Catalog Number: AT7
• Company DUNS: 460060916
• Company Name: INDIBA SA.
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08434251000915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161458

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: 2021-04-14
• Device Publish Date: 2021-04-06

Devices Manufactured by INDIBA SA.

• 08434251004173 - REVERSO PRO SYSTEM: 2025-08-08 Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
• 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