XOD Diathermia Radiofrequency Device

K242175 · Xod, Inc. · PBX · Feb 27, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K242175
• Device Name: XOD Diathermia Radiofrequency Device
• Applicant: Xod, Inc.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Feb 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.

Device Story

Device generates high-frequency sinusoidal current (442kHz-454MHz) for monopolar RF therapy; consists of portable power console with touchscreen, resistive threaded electrodes, and silicon return plate. Therapist manipulates handheld electrode while fixed electrode contacts patient to close electrical circuit. Used in clinical settings to elevate tissue temperature (40-45°C). Output provides therapeutic heating; affects clinical decision-making by facilitating pain relief, muscle spasm reduction, and improved circulation. Benefits include non-invasive treatment for specified conditions and temporary cellulite reduction.

Clinical Evidence

Bench testing only. Device performance verified against design specifications. Electrical safety testing per IEC 60601-1 and IEC 60601-1-6; EMC testing per IEC 60601-1-2; biocompatibility assessment per ISO 10993-1.

Technological Characteristics

Portable console with color touchscreen; resistive threaded electrodes; silicon return plate. Energy source: high-frequency sinusoidal current (442kHz-454MHz). Monopolar application. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1/1-6; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients requiring topical heating for relief of pain, muscle spasms, and increased local circulation, or temporary reduction in the appearance of cellulite.

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

• Indiba Diathermia Radiofrequency Device (K161458)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 27, 2025

XOD Inc. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K242175

Trade/Device Name: XOD Diathermia Radiofrequency Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: January 21, 2025 Received: January 21, 2025

Dear Angela Blackwell:

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 (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 (OS) 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 Rule"). 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-udi-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 medical devices and radiation-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 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-regulatory

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assistance/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,

James H. Digitally signed by
James H. Jang -S
Date: 2025.02.27
Jang -S
13:38:15-05'00'

For 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)

K242175

Device Name

XOD Diathermia Radiofrequency Device

### Indications for Use (Describe)

The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also 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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#### K242175

## XOD Diathermia Radiofrequency Device 510K Summary February 25, 2025

#### Name and Address: XOD Inc.

3245 Amber St. Philadelphia, PA 19134 Contact Person: Ron Gardi Email: [e-mail] Telephone: [phone]

Name of device: XOD Diathermia Radiofrequency Device Classification Name: massager, vacuum, radio induced heat CFR: 21 CFR 878.4400 Primary Product Code: PBX

#### Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 [phone] [e-mail]

Device Description: The XOD diathermia radiofrequency device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed, and RF therapy can be provided. The device can be operated in a resistive monopolar mode.

The product consists of a portable power console with a color touchscreen, and accessories including resistive threaded electrodes, and a silicon return plate. The unit can be adjusted to provide various levels of treatment frequency ranging from 442kHz to 454MHz.

Indications for Use: The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.

Testing Summary: EMC testing shows the device meets IEC 60601-1-2. Electrical safety testing shows the device meets IEC 60601-1 and IEC 60601-1-6. The device components which contact the patient or the user were evaluated according to ISO 10993-1. Performance testing shows the device meets the design specifications.

Predicate Devices: K161458 Indiba Diathermia Radiofrequency Device

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## Substantial Equivalence:

XOD's diathermia radiofrequency device is substantially equivalent to Indiba's because they have the same indications, device description, the same principle of operation and similar operating parameters.

| | XOD<br>Diathermia<br>Radiofrequency<br>Device | Indiba Diathermia<br>Radiofrequency<br>Device K161458<br>Predicate Device |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PBX | PBX |
| Indications for Use | The XOD<br>diathermia<br>radiofrequency<br>device is<br>intended to<br>provide topical<br>heating for the<br>purpose of<br>elevating tissue<br>temperature for<br>the treatment of<br>selected medical<br>conditions such<br>as relief of pain,<br>muscle spasms,<br>and increase in<br>local circulation.<br>The XOD device<br>also is intended<br>to provide a<br>temporary<br>reduction in the<br>appearance of<br>cellulite. | The Indiba<br>Diathermia<br>Radiofrequency<br>Devices are<br>intended to<br>provide topical<br>heating for the<br>purpose of<br>elevating tissue<br>temperature for<br>treatment of<br>selected<br>medical conditions<br>such as: relief of<br>pain, muscle<br>spasms, increase<br>in local<br>circulation.<br>The massage<br>device provided is<br>intended to<br>provide a<br>temporary<br>reduction in the<br>appearance of<br>cellulite. |
| Device Description | The XOD<br>diathermia<br>radiofrequency<br>device generates<br>high frequency<br>sinusoidal<br>current with a<br>monopolar mode | The Indiba<br>Diathermia<br>Radiofrequency<br>Device is a<br>therapeutic device<br>for deep,<br>non-invasive<br>diathermy The |
| of application | device consists of | |
| using two | a console which | |
| electrodes. A | generates a | |
| fixed electrode is | radiofrequency | |
| placed in contact | current which is | |
| with the patient | delivered to the | |
| and a handheld | patient, in | |
| electrode is | monopolar form, | |
| manipulated by a | through two | |
| therapist. When | different types of | |
| both electrodes | electrodes: | |
| are in contact | stainless steel | |
| with a patient the | conductive | |
| electrical circuit | resistive | |
| is closed, and RF | electrodes, and | |
| therapy can be | thin-layer | |
| provided. The | insulated | |
| device can be | capacitive | |
| operated in a | electrodes. The | |
| resistive | electrodes are | |
| monopolar | inserted into a | |
| mode. | handle/handpiece, | |
| The product | one handle for | |
| consists of a | each kind of | |
| portable power | electrode, and the | |
| console with a | handle is | |
| color | connected to the | |
| touchscreen, and | console by means | |
| accessories | of a 2-metre | |
| including | cable. | |
| resistive | In resistive mode | |
| threaded | the system | |
| electrodes, and a | delivers a high- | |
| silicon return | frequency current | |
| plate. The unit | of 448 kHz directly | |
| can be adjusted | to the patient's | |
| to provide | skin surface. In | |
| various levels of | capacitive mode, | |
| treatment | the electrode | |
| frequency | coating creates a | |
| ranging from | layer between the | |
| 442kHz to | electrode and the | |
| 454MHz. | human tissue, | |
| | forming a | |
| | capacitor that | |
| | allows | |
| | a high-frequency | |
| | | |
| | current to pass. | |
| | The high<br>frequency current<br>ranges between<br>400<br>kHz and 449 kHz<br>and is<br>automatically<br>tuned by the<br>equipment<br>according to the<br>patient's<br>impedance.<br>Current returns<br>through the<br>neutral return<br>electrode. The<br>Indiba Diathermia<br>Radiofrequency<br>Device is provided<br>with an<br>electroconductive<br>media which is<br>applied to the<br>patients' skin prior<br>to each treatment<br>session.<br>The RF energy<br>generates a<br>heating profile<br>that produces a<br>moderate<br>temperature<br>rise in the<br>subcutaneous<br>tissue.<br>The temperature<br>on the skin is<br>measured using a<br>separate IR (Infra-<br>red)<br>thermometer and<br>there is an<br>integrated<br>massage device<br>that can be used<br>to | |
| massage the skin during cellulite treatment. |…