BACK 4

K230167 · Swims America Corp · IPF · Sep 14, 2023 · Physical Medicine

Device Facts

• Record ID: K230167
• Device Name: BACK 4
• Applicant: Swims America Corp
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions. The BACK 4 device in RF mode 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 BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BACK 4 device in EMS mode is intended for: Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion. The RF treatment mode and EMS mode should not be used in combination or sequentially.

Device Story

BACK 4 is a cart-mounted console with LCD touch screen, power supply, and handheld electrodes; used in hospital or clinic settings by therapists. Device generates high-frequency sinusoidal current (300kHz-1MHz) for RF therapy (capacitive, resistive, multipolar modes) to elevate tissue temperature. Also generates 4kHz or 1.5kHz electrostimulation signals (modulated 2-200Hz) for EMS. Therapist manipulates active electrode while neutral electrode contacts patient to close circuit. Emergency stop button allows patient to shut down unit. Output affects muscle tissue and local circulation; benefits include pain relief, muscle re-education, and temporary cellulite reduction. RF and EMS modes are not used simultaneously or sequentially.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and nerve/muscle stimulator safety (IEC 60601-2-10). Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) performed on tissue-contacting probes. Human tissue temperature elevation study conducted on three subjects across three body parts at various power settings to verify therapeutic temperature maintenance.

Technological Characteristics

Cart-mounted console; RF (300kHz-1MHz) and EMS (4kHz/1.5kHz carrier, 2-200Hz modulation) energy sources. Materials: Biocompatible tissue-contacting probes (ISO 10993-1). Connectivity: Standalone. Sterilization: N/A. Electrical safety: IEC 60601-1, IEC 60601-2-10. EMC: IEC 60601-1-2. User interface: LCD touch screen. Output: Monopolar/multipolar RF; Biphasic symmetrical EMS waveform.

Indications for Use

Indicated for patients requiring relief of pain, muscle spasms, increased local circulation, temporary reduction in cellulite appearance, prevention/retardation of disuse atrophy, muscle re-education, or maintenance/increase of range of motion. Contraindicated for use of RF and EMS modes in combination or sequentially.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• BACK3 COLOR (K214090)
• Evolve System with the T3 Applicator (K210877)

Submission Summary (Full Text)

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September 14, 2023

SWIMS America Corp Matthieu Commeau Managing Director 1133 Westchester Avenue Suite N 220 White Plains, New York 10604

Re: K230167

Trade/Device Name: BACK 4 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. PBX Dated: August 17, 2023 Received: August 17, 2023

Dear Matthieu Commeau:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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,

# Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230167

Device Name BACK 4

#### Indications for Use (Describe)

The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 4 device in RF mode 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 BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 4 device in EMS mode is intended for:

- *Prevention or retardation of disuse atrophy
*Increasing local blood circulation

*Muscle re-education

*Maintaining or increasing range of motion.

The RF treatment mode and EMS mode should not be used in combination or sequentially.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Premarket Notification SWIMS America Corp K230167 Section 1.5

## 510(k) Summary

### Date : 09/13/2023

| 1. | Submitted By: | SWIMS America Corp<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604<br>Tel. [phone] |
|----|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person : | Mr. Matthieu COMMEAU<br>Managing Director of SWIMS America Corp<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604<br>Tel. [phone]<br>Email : [e-mail] |
| 3. | Common Name: | BACK4 Massager, Radiofrequency Induced Heat therapy and<br>Electrostimulation device |
| 4. | Trade Name : | BACK 4 |
| 5. | Regulation Number: | 21 CFR 890.5850 |
| 6. | Regulation Name: | Powered Muscle Stimulator |
| 7. | Device Product Codes: | IPF, PBX |
| 8. | Regulatory Class: | II |
| 9. | Predicate Devices: | Primary Predicate Device: BACK3 COLOR, K214090<br>Secondary Predicate Device: Evolve System with the T3<br>Applicator, K210877 |

#### Description:

The BACK 4 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active 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 capacitive or resistive monopolar modes and a multipolar mode.

The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).

The two RF and EMS technologies should not be used in combination or sequentially.

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An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

### Intended Use:

The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 4 device in RF mode 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 BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 4 device in EMS mode is intended for:

*Prevention or retardation of disuse atrophy

*Increasing local blood circulation

*Muscle re-education

*Maintaining or increasing range of motion.

The RF treatment mode and EMS mode should not be used in combination or sequentially.

#### Substantial Equivalence/Technological Characteristics:

The BACK 4 device is substantially equivalent to the following primary and secondary devices for the technology RF and EMS accordingly.

| Device | Manufacturer | 510(k) No. | Technical characteristics similar to the Subject device |
|-----------------------------------------------------------------------|-----------------|------------------------------|---------------------------------------------------------|
| <b>Primary device</b> | | | |
| BACK3 COLOR<br>Product codes: PBX | Daeyang Medical | K214090 (SWIMS America Corp) | RF technology (300kHz-1MHz) |
| <b>Secondary device</b> | | | |
| Evolve System with the T3 Applicator<br>Product codes : IPF, PBX, GZJ | InMode Ltd. | K210877 | EMS technology signals |

#### A Primary predicate device (RF technology)

The BACK 4 device is substantially equivalent to the BACK3 COLOR device from SWIMS America Corp which was cleared under premarket notification K214090. Both devices are cart mounted consoles with electrode accessories capable of operation in monopolar and multipolar modes in the range of 300kHz to 1MHz radiofrequency.

Both devices operate in the same treatment range and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.

#### > Secondary predicate device (EMS technology)

The BACK 4 device shares also the same intended use and Product codes (PBX, IPF) as the FDA-Cleared Evolve System with the T3 Applicator (K210877). Both devices are also designed to deliver electro-muscle stimulation (EMS) for the treatment of different body areas for various medical

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applications. These devices have the same range of frequencies (Subject Device: 2-200 Hz; Secondary Predicate: 3-200 Hz).

Indeed, both devices have specifications in common:

- A Main Line Frequency (nominal): 50-60 Hz
- Input Voltage (nominal): 100 240 VAC. A

Please note that the Subject device does not follow the Product code GZJ, which the secondary predicate does follow. That is why some intended uses linked to this Product Code are not found in the intended use of the Subject device: Symptomatic relief and management of chronic, intractable postsurgical acute pain.

These minor differences in technical specifications should not alter the device safety and effectiveness. Furthermore, the Subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards.

The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate devices. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601- 2-10 standard.

All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the BACK 4 is substantially equivalent to its predicate device and can be sold in the US market.

The table below summarizes the equivalence of the devices.

### Predicate Device Comparison Table

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| SWIMS America Corp<br>K230167 | | | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element of<br>Comparison | 510(k) Device:<br>BACK 4 | Primary Predicate Device:<br>BACK3 COLOR<br>K214090 | Secondary Predicate Device:<br>Evolve System with the T3<br>Applicator<br>K210877 | Explanation of Differences |
| Regulation and<br>Product Classification<br>Codes | 21 CFR 890.5850 (IPF)<br>21 CFR 878.4400 (PBX) | 21 CFR 878.4400 (PBX) | 21 CFR 890.5850 (IPF)<br>21 CFR 878.4400 (PBX)<br>21 CFR 882.5890 (GZJ) | The BACK 4 device follows the same Product<br>codes as the two predicate devices: PBX, IPF.<br>However, BACK 4 does not use the code GZJ-<br>Transcutaneous electrical nerve stimulator for<br>pain relief. Therefore, BACK 4 does not have<br>the indications for use of the GZJ Product Code.<br>This does not raise new questions of safety and<br>effectiveness. |
| Prescription/OTC | Prescription | Prescription | Prescription | Identical |
| Indications for Use | The BACK 4 device employs RF<br>technology or EMS technology for the<br>treatment of selected medical<br>conditions.<br><br>PBX code: The BACK 4 device in RF<br>mode is intended to provide topical<br>heating for the purpose of elevating<br>tissue temperature for the treatment of<br>selected medical conditions such as<br>relief of pain, muscle spasms, and<br>increase in local circulation.<br>The BACK 4 massage device is<br>intended to provide a temporary<br>reduction in the appearance of cellulite.<br><br>IPF code:<br>The BACK 4 device in EMS mode is<br>intended for:<br>*Prevention or retardation of disuse<br>atrophy<br>*Increasing local blood circulation<br>*Muscle re-education<br>*Maintaining or increasing range of<br>motion. | PBX code: The BACK3 COLOR<br>device is intended to provide topical<br>heating for the purpose of elevating<br>tissue temperature for the treatment<br>of selected medical conditions such<br>as relief of pain, muscle spasms, and<br>increase in local circulation.<br>The BACK3 COLOR massage<br>device is intended to provide a<br>temporary reduction in the<br>appearance of cellulite. | The Evolve System with the T3<br>Applicator employs RF<br>technology or EMS-TENS<br>technology for the treatment of<br>selected medical conditions.<br><br>PBX code:<br>The T3 Applicator in RF mode<br>is intended for the temporary<br>relief of minor muscles aches<br>and pain, temporary relief of<br>muscle spasm, and temporary<br>improvement of local blood<br>circulation.<br><br>IPF code:<br>The T3 Applicator in EMS<br>mode is intended for:<br>*Relaxation of muscle spasms<br>*Prevention or retardation of<br>disuse atrophy<br>*Increasing local blood<br>circulation<br>*Muscle re-education<br>*Maintaining or increasing<br>range of motion | The BACK 4 device shares the same intended<br>for use as BACK3 COLOR and Evolve System<br>for the RF technology (PBX code).<br><br>Also, the BACK 4 device has less indications<br>for use than Evolve System with the T3<br>Applicator for EMS-TENS modes.<br><br>Therefore, the BACK 4 device does not have<br>new indications for use compared to the two<br>predicate devices for RF and EMS<br>technologies. This does not raise new questions<br>of safety and effectiveness. |

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#### 510(k) Premarket Notification SWIMS America Corp K230167 The RF treatment mode and EMS mode *Immediate post-surgical stimulation of calf muscles to should not be used in combination or prevent venous thrombosis. sequentially. GZJ code: The T3 Applicator in TENS mode is intended for: *Symptomatic and management of chronic, intractable pain *Post-surgical acute pain *Post-trauma acute pain. The RF treatment mode and EMS/TENS mode should not be used in in combination or sequentially. Hospital or Clinic setting Environment Used Hospital or Clinic setting Hospital or Clinic setting Identical IEC 60601-1: General requirements IEC 60601-1: General requirements Performance IEC 60601-1: General The BACK 4 device complies to the same standards (FDA for basic safety and essential for basic safety and essential requirements for basic safety performance standards as the two predicate recognized consensus performance performance and essential performance devices, except to standards) IEC 60601-2-2 as the Subject device is not IEC 60601-1-2: General requirements IEC 60601-1-2: General IEC 60601-1-2: General intended to be used in a surgical environment for basic safety and essential requirements for basic safety and requirements for basic safety nor in an emergency. Also, the BACK 4 device performance - Collateral Standard: essential performance - Collateral and essential performance is not a life supporting device. This does not Electromagnetic disturbances -Standard: Electromagnetic Collateral Standard: raise new questions of safety and effectiveness. Requirements and tests. disturbances - Requirements and Electromagnetic disturbances tests. Requirements and tests. IEC 60601-2-10: particular IEC 60601-2-10: particular requirements for the Basic Safety and IEC 60601-2-10: particular Essential Performance of Nerve and requirements for the Basic Safety requirements for the Basic Muscle stimulators. and Essential Performance of Nerve Safety and Essential and Muscle stimulators. Performance of Nerve and IEC 60601-1-6: General requirements Muscle stimulators. for basic safety and essential IEC 60601-1-6: General performance -Collateral standard: requirements for basic safety and IEC 60601-1-6: General Usability. essential performance -Collateral requirements for basic safety standard: Usability. and essential performance -Collateral standard: Usability.

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| | | 510(k) Premarket Notification | | | |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | SWIMS America Corp | | | |
| | | K230167 | | | |
| | | | EN IEC 60601-2-2 :Particular<br>requirements for the basic safety<br>and essential performance of<br>high-frequency surgical<br>equipment and high-frequency<br>surgical accessories. | | |
| Applicator Shapes | Square, rectangular and circular | Square, rectangular and circular | Rectangular | Identical to the primary predicate device.<br>Difference in shape compared to the secondary<br>predicate device. However, this difference<br>does not raise any new questions of safety and<br>effectiveness compared to the secondary<br>predicate device. The biocompatibility testing<br>and usability attest of the safety of these<br>accessories. | |
| Infrared Light | No | No | No | Identical | |
| Vacuum (suction) | No | No | No | Identical | |
| Applied energy | RF/EMS | RF | RF/EMS-TENS | The BACK 4 device has the same RF<br>technological characteristics as the primary<br>predicate device.<br>The subject device can apply the same energy<br>EMS as the secondary predicate device.<br>However, the BACK 4 does not use GZJ as the<br>secondary predicate device does. So, the<br>subject device does not have TENS energy.<br>This does not raise new questions of safety and<br>effectiveness. | |
| Power source | Main line frequency (nominal): 50-<br>60Hz.<br>Input Voltage (nominal):<br>100-<br>240VAC.<br>Input current (rms): 1.25Aac<br>@240Vac and 3Aac @ 100Vac. | Main line frequency (nominal): 50-<br>60Hz.<br>Input Voltage (nominal):<br>100-<br>240VAC.<br>Input current (rms): 1.25Aac<br>@240Vac and 3Aac @ 100Vac. | Main line frequency (nominal):<br>50-60Hz.<br>Input Voltage (nominal): 100-<br>240VAC.<br>Input current (rms): 4A. | Power source characteristics are identical to the<br>primary predicate device.<br>The power source characteristics are different<br>to those of the secondary predicate device. The<br>main line frequency and input voltage are<br>similar, except for the input current. However,<br>this difference does not raise new safety and<br>effectiveness questions as electrical safety<br>testing has been performed following state of<br>the art standards. | |
| | | | | | |
| RF Type | Multipolar/Unipolar | Multipolar/Unipolar | Multipolar/Unipolar | Identical | |
| RF Frequency | 300kHz – 1MHz | 300kHz – 1MHz | 1MHz | Identical to the Primary predicate device for RF<br>technology.<br>The RF frequency of the secondary device falls<br>within range of the subject device.<br>This difference does not raise any new<br>questions of safety and effectiveness compared<br>to the secondary predicate device. | |
| Maximum RF output<br>Power | 300W | 300W | 75W | Identical to the primary predicate device.<br>Different from the secondary predicate device.<br>However, this difference does not raise new<br>questions of safety and effectiveness. RF output<br>power has already been cleared with the<br>primary predicate device. | |
| Electrical type | Type BF | Type BF | Type BF | Identical | |
| EMS output<br>specifications;<br>waveform | Biphasic with symmetrical waveform | N.A | Symmetrical<br>Biphasic waveform | Identical | |
| EMS Frequency | 2 to 200Hz | N.A | 3 to 200 Hz | Not identical.<br>The EMS frequency range of the subject device<br>has minor difference to the secondary predicate<br>device.<br>This difference does not raise any new<br>questions of safety and effectiveness compared<br>to the secondary predicate device.<br>This characteristic does not apply to the<br>primary predicate device. | |
| Patient Leakage<br>Current -Normal<br>Condition (uA) | <50uA patient leakage | N.A | <100uA patient leakage | Not identical.<br>Patient leakage current range has minor<br>difference to the patient leakage current range<br>of the secondary predicate device.<br>This difference does not raise any new<br>questions of safety and effectiveness compared<br>to the secondary predicate device.<br>This characteristic does not apply to the<br>primary predicate device. | |
| Patient Leakage<br>Current-Single Fault<br>condition (uA) | <300uA line leakage | N.A | <300uA line leakage | Identical to the secondary predicate device.<br>This characteristic does not apply to the<br>primary predicate device. | |
| Number of Output<br>channels | 3 | 3 | 6 | Not identical.<br>The BACK 4 device has less output channels<br>than the secondary predicate device. This does<br>not raise new questions of safety and<br>effectiveness. | |
| Console | Console, including a power supply<br>unit, controller, and user interface<br>including a LCD touch screen. | Console, including a power supply<br>unit, controller, and user interface<br>including a LCD touch screen. | Console, including a power<br>supply unit, controller, and user<br>interface including a LCD touch<br>screen. | Identical | |
| Software control | Yes | Yes | Yes | Identical | |
| Indicator Display | On/Off status<br>Voltage/current level | On/Off status<br>Voltage/current level | On/Off status<br>Voltage/current level | Identical | |
| Battery | No | No | No | Identical | |
| Timer Range<br>(minutes) | 0-60 (minutes) | 0-60 (minutes) | 0-60 (minutes) | Identical | |
| Accessories provided | TECAR X handset | / | T3 Applicator: | Comparison with the primary predicate device: | |
| with the device<br>(diameter of the…