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

K241107 · Indiba S. A. U. · PBX · Jan 24, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K241107
• Device Name: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
• Applicant: Indiba S. A. U.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Jan 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Indiba Diathermia Radiofrequency devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Device Story

Non-invasive diathermy devices (Activ CT9, EVONY) use monopolar radiofrequency (RF) current to elevate tissue temperature. Console generates 448 kHz RF current delivered via capacitive (CAP) or resistive (RES) electrodes; return path via neutral electrode. Activ CT9 includes mechanical massage applicators for cellulite reduction. Devices feature touchscreen interfaces for setting parameters; EVONY includes smart handles/electrodes for automatic applicator identification and temperature tracking. Used in clinical settings by trained operators. Output provides therapeutic heating; healthcare providers use device to manage pain, muscle spasms, and circulation. Benefits include non-invasive symptom relief and aesthetic improvement.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included software verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and RF power control accuracy testing.

Technological Characteristics

Monopolar RF diathermy; 448 kHz output frequency; 200W (RES) / 450VA (CAP) max power. Materials: AISI 304L stainless steel electrodes, polyamide #12 insulation. Connectivity: Touchscreen interface, smart handle identification. Sterilization: Not specified. Software: Embedded control system.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasm reduction, or increased local circulation. The Activ CT9 model is also indicated for temporary reduction in the appearance of cellulite via mechanical massage.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Activ 902 (K161458)
• ELITE (K161458)

Submission Summary (Full Text)

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January 24, 2025

Indiba S.A.U % Amit Goren Head of Regulatory Affairs A. stein Regulatory Affairs Consulting Company Ltd. 18 Hata'as St. Kfar Saba, 4442518 Israel

Re: K241107

Trade/Device Name: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: October 28, 2024 Received: October 29, 2024

Dear Amit Goren:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long H. Chen -S-s
Digitally signed by Long H. Chen
Date: 2025.01.24 15:20:56 -05'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K241107

Device Name

Indiba Diathermia Radiofrequency Deep Care Device

(IDC0409/EVONY);

Indiba Diathermia Radiofrequency Activ Device (ACT0309/Activ CT9)

Indications for Use (Describe)

The Indiba Diathermia Radiofrequency Deep Care/Activ devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# INDIBA DIATHERMIA RADIOFREQUENCY ACTIV DEVICE, INDIBA DIATHERMIA RADIOFREQUENCY DEEP CARE DEVICE 510(K) SUMMARY

# 510(k) Number K241107

## Applicant Name:

| Company Name: | INDIBA S.A.U. |
|---------------|----------------------------------------------------------------------------------------------|
| Address: | C/ Moianès, 13 – P.I. Can Casablanques<br>Sant Quirze del Vallès (Barcelona), 08192<br>Spain |
| | Tel: [phone] |
| | E-mail: [e-mail] |

## Contact Person:

| Official Correspondent: | Amit Goren |
|-------------------------|------------------------------------------------------------|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd |
| Address: | 18 Hata'as Str.<br>Kfar Saba 4442518<br>Israel |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | October 28, 2024 |
| Trade Name: | Activ CT9 device, EVONY device |
| Classification Name: | CFR Classification section 878.4400;<br>(Product code PBX) |
| Classification: | Class II Medical Device |

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

Predicate Devices: The INDIBA Diathermia Radiofrequency Activ Device model (Activ CT9 device) and The INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device) are substantially equivalent to the following predicate devices;

| Manufacturer | Device | 510(k) No. |
|---------------|-----------|------------|
| Indiba S.A.U. | Activ 902 | K161458 |
| Indiba S.A.U. | ELITE | K161458 |

### Device Description:

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.

The device models consist of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes, stainless steel conductive resistive electrodes (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.

The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.

The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.

The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.

Improvements were performed in both device models in the console design and in the graphical user interface (GUI).

New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission - 510(K) Summary

All of the device improvements and modifications do not pose any new risks for the device safety and effectiveness.

The Activ CT9 and the EVONY device models, bearing the same technical specifications:

| Feature | Subject device models | |
|-------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------|
| | Activ CT9 | EVONY |
| Weight | 9.5 kg | 50 kg (includes trolley) |
| Size | 400 mm (width)<br>530 mm (depth)<br>150 mm (height, with display folded) | 670 mm (width)<br>530 mm (depth)<br>1370 mm (height) |
| Input Mains Supply | (100 - 240) VAC 50/60 Hz | (100 - 240) VAC 50/60 Hz |
| Display | 8" color TFT<br>(800 x 480 pixels) | 21.5" color TFT<br>(1920 x 1080 pixels) |
| User input interface | Touchscreen | Touchscreen |
| Output frequency in<br>RES mode | 448 kHz | 448 kHz |
| Output frequency<br>range in CAP mode | 448 kHz | 448 kHz |
| Maximum output<br>power in RES mode | 200 W | 200 W |
| Maximum output<br>power in CAP mode | 450 VA | 450 VA |
| Temperature range for<br>operation: | +10°C to +40°C | +10°C to +40°C |
| Temperature range for<br>storage and transport: | -20°C to +50°C | -20°C to +50°C |
| Timer range: | 0 - 99 minutes | 0 - 99 minutes |

## Intended Use/Indication for Use:

The Indiba Diathermia Radiofrequency devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

## Performance Standards:

The INDIBA Diathermia Radiofrequency Activ device model has been tested and complies with the following voluntary recognized standards:

- ES60601-1:2005/(R)2012 ● AAMI C1:2009/(R)2012 ANSI &A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

The INDIBA Diathermia Radiofrequency Deep Care device model has been tested and complies with the following voluntary recognized standards:

- AAMI ES60601-1:2005/(R)2012 C1:2009/(R)2012 ANSI &A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment ● - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

## Non-Clinical (Bench) Performance Data:

The following validation activities were performed:

- Software Verification and Validation Testing
- Electrical safety and EMC testing
- Power control and RF accuracy testing ●
- Labeling Verification and Validation Testing ●

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Indiba Diathermia Radiofrequency Activ Device, Indiba Diathermia Radiofrequency Deep Care Device 510(k) submission – 510(K) Summary

All of the validation activities were performed using the same testing techniques and principles as performed using the predicate device models. The results of the above listed validation activities conclude that the INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model are safe and effective for their intended use and user population (both users and patients) and that the modified device models are substantially equivalent to their respective predicate devices.

#### Animal Performance Data / Histology Data:

Not Applicable

#### Clinical Performance Data:

Not Applicable

#### Biocompatibility

All of the modified device models' materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the manufacturing of the predicate device models all manufactured by INDIBA S.A.U.

#### Substantial Equivalence:

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model are substantially equivalent to the INDIBA Diathermia Radiofrequency Activ 902 device model and to the INDIBA Diathermia Radiofrequency ELITE device model respectively, all manufactured by INDIBA S.A.U., and the subject of K161458. The subject device models and predicate device models share the same underlying technology of mono-polar RF, the same RF output specifications and same operational principles.

A comparison table is provided below comparing the intended use and basic technological characteristics of the subject device models to the intended use and basic technological characteristics of the predicate device models.

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| | ELITE<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | EVONY Device<br>Subject device;<br>INDIBA S.A.U | Activ 902<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | Activ CT9 Device<br>Subject device;<br>INDIBA S.A.U |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Technological Characteristics | | | | |
| Device description /<br>Design | The INDIBA Diathermia<br>Radiofrequency Device is a<br>therapeutic device for Deep,<br>non-invasive diathermy,<br>consists of a tabletop console<br>which generates a<br>radiofrequency current which<br>is delivered to the patient.<br>The device is line powered &<br>software controlled.<br>Mono-polar radiofrequency<br>(RF) current is generated in<br>the console and emitted to<br>the patient's skin by two<br>different RF electrode types:<br>RES & CAP.<br>The RF current returns to the<br>console through a neutral<br>return electrode.<br>The device comprises<br>additional massage pieces<br>that can be used to massage<br>the skin for cellulite<br>treatment. | The INDIBA Diathermia<br>Radiofrequency Device, is<br>a therapeutic device for<br>Deep, non-invasive<br>diathermy, consists of a<br>main body (console and a<br>touchscreen), and a CPU<br>unit that is also incorpor<br>ated in the main unit.<br>The device is line powered<br>& software controlled.<br>The touchscreen comprises<br>user interface and enables<br>the user to predefine the<br>device treatment settings<br>and facilitate the user<br>device operation.<br>Mono-polar radiofrequency<br>(RF) current is generated in<br>the console and emitted to<br>the patient's skin by two<br>different RF electrode<br>types: RES & CAP<br>installed on a smart handle. | The INDIBA Diathermia<br>Radiofrequency Device is a<br>therapeutic device for<br>Activ, non-invasive<br>diathermy, consists of a<br>tabletop console which<br>generates a radiofrequency<br>current which is delivered<br>to the patient.<br>The device is line powered<br>& software controlled.<br>Mono-polar radiofrequency<br>(RF) current is generated in<br>the console and emitted to<br>the patient's skin by two<br>different RF electrode<br>types: RES & CAP.<br>The RF current returns to<br>the console through a<br>neutral return electrode.<br>The device comprises<br>additional massage pieces<br>that can be used to massage | The INDIBA Diathermia<br>Radiofrequency Device,<br>is a therapeutic device<br>for Activ, non-invasive<br>diathermy, consists of a<br>tabletop console (console<br>and a touchscreen) which<br>generates a<br>radiofrequency current<br>which is delivered to the<br>patient.<br>The device is line<br>powered & software<br>controlled.<br>The touchscreen<br>comprises user interface<br>and enables the user to<br>predefine the device<br>treatment settings and<br>facilitate the user device<br>operation.<br>Mono-polar<br>radiofrequency (RF)<br>current is generated in |
| | ELITE<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | EVONY Device<br>Subject device;<br>INDIBA S.A.U | Activ 902<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | Activ CT9 Device<br>Subject device;<br>INDIBA S.A.U |
| | | The device comprises the<br>sculpture electrodes for<br>additional treatment<br>options.<br>The RF current returns to<br>the console through a<br>neutral return electrode. | the skin for cellulite<br>treatment. | the console and emitted<br>to the patient's skin by<br>two different RF<br>electrode types: RES &<br>CAP.<br>The device comprises the<br>fascia electrodes for<br>additional treatment<br>options.<br>The RF current returns to<br>the console through a<br>neutral return electrode.<br>The device comprises<br>additional massage<br>pieces that can be used to<br>massage the skin for<br>cellulite treatment. |
| Device components | The ELITE Device model<br>consists of the following<br>components:<br>Console, which<br>contains the following<br>components:<br>RF Generator Control unit (CPU) | The IDC0409 Device model<br>consists of the following<br>components:<br>Console, which<br>contains the<br>following<br>components:<br>RF Generator | The Activ 902 Device model<br>consists of the following<br>components:<br>Console, which<br>contains the following<br>components:<br>RF Generator Control unit (CPU) | The Activ CT9 Device<br>model consists of the<br>following components:<br>Console, which<br>contains the<br>following<br>components:<br>RF Generator |
| ELITE<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | EVONY Device<br>Subject device;<br>INDIBA S.A.U | Activ 902<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | Activ CT9 Device<br>Subject device;<br>INDIBA S.A.U | |
| o Device bottom panel<br>o Incorporated display<br>screen<br>o Outlets connectors for<br>treatment handles and<br>return electrode | o Control unit (CPU)<br>o Device bottom panel<br>o Touchscreen displays<br>with GUI<br>o Outlets connectors<br>for treatment handles<br>and return electrode | o Device bottom panel<br>o Incorporated display<br>screen<br>o Outlets connectors for<br>treatment handles and<br>return electrode | o Control unit (CPU)<br>o Incorporated flip<br>display screen<br>o Touchscreen<br>displays with GUI<br>o Outlets connectors<br>for treatment<br>handles and return<br>electrode | |
| The ELITE Device accessories:<br>• Handles<br>• Diathermia treatment<br>electrodes:<br>o Thin-layer insulated<br>electrodes (called<br>"Capacitive" or "CAP"<br>electrodes by INDIBA,<br>S.A.U). The insulated<br>material is polyamide | The IDC0409 Device<br>accessories:<br>• Smart Handle<br>• Diathermia treatment<br>electrodes with<br>indicative thermal<br>sensors imbedded in<br>them:<br>o Thin-layer insulated | The Activ 902 Device<br>accessories:<br>• Handles<br>• Diathermia treatment<br>electrodes:<br>o Thin-layer insulated<br>electrodes (called<br>"Capacitive" or "CAP"<br>electrodes by INDIBA<br>S.A.U). The insulated<br>material is polyamide | The Activ CT9 Device<br>accessories:<br>• Diathermia<br>treatment<br>electrodes:<br>o Thin-layer insulated<br>electrodes (called<br>"Capacitive" or<br>"CAP" electrodes by<br>INDIBA S.A.U).<br>The insulated<br>material is<br>polyamide #12.<br>Circular shape, sizes: | |
| #12. Circular shape,<br>sizes: 30, 40, 55, 65, 80<br>mm diameter.<br>o Stainless steel<br>conductive metal<br>electrodes (AISI 304L) | electrodes (called<br>"Capacitive" or<br>"CAP" electrodes by<br>INDIBA S.A.U). The<br>insulated material is<br>polyamide #12. | #12. Circular shape,<br>sizes: 30, 40, 55, 65, 80<br>mm diameter.<br>o Stainless steel<br>conductive metal | 12, 19, 25, 30, 40 | |
| ELITE<br>Predicate Device;<br>INDIBA S.A.U | EVONY Device<br>Subject device;<br>INDIBA S.A.U | Activ 902<br>Predicate Device;<br>INDIBA S.A.U | Activ CT9 Device<br>Subject device;<br>INDIBA S.A.U | |
| K161458 | | K161458 | | |
| (called "Resistive" or<br>"RES" electrodes by<br>INDIBA S.A.U),<br>circular shape, sizes:<br>35, 50, 65, 90 mm<br>diameter.<br>Return electrode (plate)<br>– stainless steel (AISI<br>304L) Massager piece IR thermometer Conductive gel Other Components Included<br>with Device: Power Supply<br>Cable Electrode Case<br>with Foam | Circular shape, sizes:<br>19, 30, 35, 40, 55, 65,<br>80 mm diameter and<br>35 mm diameter<br>curved.<br>Stainless steel<br>conductive metal<br>electrodes (AISI<br>304L) (called<br>"Resistive" or "RES"<br>electrodes by<br>INDIBA S.A.U),<br>circular shape, sizes:<br>19, 35, 50, 65, 90<br>mm diameter. Return electrode (plate)<br>with indicative thermal<br>sensors imbedded in it<br>made of stainless steel<br>(AISI 304L) Sculpture electrodes IR thermometer Conductive gel | electrodes (AISI 304L)<br>(called "Resistive" or<br>"RES" electrodes by<br>INDIBA S.A.U),<br>circular shape, sizes:<br>35, 50, 65, 90 mm<br>diameter. Return electrode<br>(plate) - stainless steel<br>(AISI 304L) Massager piece IR thermometer Conductive gel Other Components Included<br>with Device: Power Supply<br>Cable Electrode Case with<br>Foam | 55, 65, 80 mm<br>diameter. Stainless steel<br>conductive metal<br>electrodes (AISI<br>304L) (called<br>"Resistive" or<br>"RES" electrodes by<br>INDIBA S.A.U),<br>circular shape, sizes:<br>35, 50, 65, 90 mm<br>diameter. Return electrode<br>(plate) - stainless<br>steel (AISI 304L) Massager piece Fascia electrodes Target electrodes IR thermometer Conductive gel Other Components<br>Included with Device: | |
| | ELITE<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | EVONY Device<br>Subject device;<br>INDIBA S.A.U | Activ 902<br>Predicate Device;<br>INDIBA S.A.U<br>K161458 | Activ CT9 Device<br>Subject device;<br>INDIBA S.A.U |
| | | Other Components Included<br>with Device:<br>• Power Supply Cable<br>• Electrode Case with<br>foam | | • Power<br>Supply<br>Cable<br>• Electrode Case<br>with Foam |
| Input power | Input power:<br>220-240 VAC,<br>50-60 Hz | Input power:<br>100-240 VAC,<br>50-60 Hz | Input power:<br>220-240 VAC<br>50-60 Hz | Input power:<br>100-240 VAC,<br>50-60 Hz |
| Physical specifications | Dimensions:<br>458 mm W (width) x 440 mm D<br>(depth) x 170 mm H (height)<br>Weight: 14.1 kg | Cart Dimensions:<br>670 mm W (width) x 550 mm D<br>(depth) x 1,370 mm H (height)<br>Weight: 50 kg | Dimensions:<br>458 mm W (width) x 440 mm D<br>(depth) x 170 mm H (height)<br>Weight: 14.1 kg | Dimensions:<br>400 mm W (width) x 530 mm<br>D (depth) x 150 mm H (height<br>with display folded)<br>Weight: 8.6 kg |
| Output frequency in<br>RES mode | 448 kHz | Idem | 448 kHz | Idem |
| Output frequency in<br>CAP mode | 400-449 kHz | 448kHz | 400-449 kHz | 448kHz |
| Maximum output power<br>in RES mode | 200w | Idem | 200w | Idem…