(218 days)
Not Found
No
The description focuses on the physical operation and technical specifications of a radiofrequency device, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the 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" and "to provide a temporary reduction in the appearance of cellulite." These are therapeutic purposes.
No
The provided text states that the device is intended to provide topical heating for treatment, not for diagnosing conditions.
No
The device description explicitly details hardware components including a power console, electrodes, and a silicon return plate, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "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" and "a temporary reduction in the appearance of cellulite." These are therapeutic applications performed on the patient's body.
- Device Description: The device description details how it generates radiofrequency current and applies it to the patient using electrodes. This is a physical intervention on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a therapeutic device that applies energy to the body for treatment.
N/A
Intended Use / 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.
Product codes
PBX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
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.
1
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
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
Indications for Use
Submission Number (if known)
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: info@xod.life Telephone: 888-460-9042
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 (704)450-9934 angela@blackwelldevice.com
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
Diathermia
Radiofrequency
Device | Indiba Diathermia
Radiofrequency
Device K161458
Predicate Device |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PBX | PBX |
| 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. | 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 Description | The XOD
diathermia
radiofrequency
device generates
high frequency
sinusoidal
current with a
monopolar mode | The Indiba
Diathermia
Radiofrequency
Device is a
therapeutic device
for deep,
non-invasive
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
frequency current
ranges between
400
kHz and 449 kHz
and is
automatically
tuned by the
equipment
according to the
patient's
impedance.
Current returns
through the
neutral return
electrode. The
Indiba Diathermia
Radiofrequency
Device is provided
with an
electroconductive
media which is
applied to the
patients' skin prior
to each treatment
session.
The RF energy
generates a
heating profile
that produces a
moderate
temperature
rise in the
subcutaneous
tissue.
The temperature
on the skin is
measured using a
separate IR (Infra-
red)
thermometer and
there is an
integrated
massage device
that can be used
to | |
| massage the skin during cellulite treatment. | | |
| Principle of Operation | Uses radiofrequency to raise tissue temperature | Uses radiofrequency to raise tissue temperature |
| Frequency Range | 442-454kHz | 400-449kHz |
| Input Voltage Supply | (100-240) V~ 50/60 Hz
Max RF Power 350W | (100 – 130) V~ 50/60 Hz
Max RF Power 200W |
| Time of Treatment | 20-30 minutes | 0-99 minutes |
| Intensity of Treatment | 0-100% | 0-100% |
| Maximum Temperature Range for Tissue | 40-45°C | 40-45°C |
| Electrical Safety Testing Meets IEC 60601-1 and IEC 60601-1-6 | Yes | Yes for only IEC 60601-1 |
| EMC Testing Meets IEC 60601-1-2 | Yes | Yes |
| Biocompatibility Assessment According to ISO 10993 | Yes | Yes |
| Type of Electrodes and Return plates | resistive threaded electrodes
silicon return plate | resistive electrodes
capacitive electrodes
neutral plate |
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7
K242175
8
Conclusion:
The XOD Diathermia Radiofrequency Device has the similar indications (the same as those of the predicate device other than details of parts of the device) to the predicate device, the same temperature range and frequency range as the predicate device, the same type of electrodes as the predicate device, and a similar input voltage supply to the predicate device and testing to the same standards as the predicate device. Any differences are due to the physical differences of the devices due to size (portable device versus a device on a cart) but do not impact the substantial equivalence in any way.