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Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

by Indiba S.A.U.

510(k) K241107

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241107↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241107 Date24 Jan 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PBX
Models / Variants
FDA applicant
Indiba S. A. U.
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Indiba Diathermia Radiofrequency Deep Care Device and Activ Device are radiofrequency-induced heat devices designed for therapeutic applications. They deliver controlled energy to stimulate tissue regeneration, reduce inflammation, and improve circulation, primarily used in general and plastic surgery settings. These devices operate by generating deep tissue heating to enhance cellular activity and promote healing processes.

These devices are supplied as reusable medical equipment and are intended for use in clinical environments. They are classified as Class II devices under FDA regulations and comply with the Medical Device Regulation (MDR). The Deep Care IDC0409/EVONY and Activ ACT0309/CT9 models are authorized under FDA 510(k) clearance and MDR, ensuring adherence to safety and performance standards. No specific sterility or MRI safety information is provided in the data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the primary clinical applications for the Indiba Diathermia Radiofrequency Deep Care and Activ Devices in surgical settings?

    The Indiba Diathermia Radiofrequency Deep Care and Activ Devices are designed to deliver controlled radiofrequency-induced heat for therapeutic purposes. Clinically, they are used to stimulate tissue regeneration, reduce inflammation, and improve circulation—particularly in general and plastic surgery contexts. These devices target deep tissue heating to enhance cellular activity and support healing processes, making them suitable for postoperative recovery and tissue repair scenarios.

  • Are the Indiba Diathermia Deep Care and Activ Devices single-use or reusable, and what does this mean for clinical workflows?

    The Indiba Diathermia Deep Care (IDC0409/EVONY) and Activ (ACT0309/CT9) devices are explicitly labeled as reusable medical equipment. This means they are intended for repeated use in clinical environments after proper cleaning, disinfection, and maintenance, reducing waste and cost compared to single-use alternatives. Clinicians should follow manufacturer guidelines for reprocessing to ensure safety and performance.

  • What regulatory pathways have the Indiba Diathermia Deep Care and Activ Devices undergone, and how does this affect their use in clinical practice?

    Both devices have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). The FDA classification is Class II, and they are deemed *substantially equivalent* to predicate devices, ensuring they meet established safety and performance standards. Clinicians can rely on these clearances as evidence of regulatory scrutiny, though local compliance with reprocessing protocols (e.g., cleaning, sterilization) remains critical for safe reuse.

  • How should the Indiba Diathermia devices be stored to maintain their functionality and safety?

    While specific storage instructions aren’t detailed in the provided data, reusable medical devices like these typically require protection from physical damage, contamination, and environmental extremes (e.g., moisture, extreme temperatures). Clinicians should store them in a clean, dry environment, following manufacturer-recommended guidelines to preserve functionality and ensure compliance with infection control protocols. Avoid exposure to direct sunlight or corrosive substances.