BACK 3

K230037 · Swims America Corp · PBX · Jul 19, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230037
• Device Name: BACK 3
• Applicant: Swims America Corp
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Jul 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BACK 3 device employs RF technology or EMS technology for the treatment of selected medical conditions. The BACK 3 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 3 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BACK 3 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 3 is a cart-mounted console with an LCD touch screen, power supply, and various electrode accessories (capacitive, resistive, multipolar). It operates in two modes: RF (300kHz-1MHz) for topical heating and EMS (4kHz/1.5kHz signal modulated at 2-200Hz) for muscle stimulation. A therapist manipulates the handheld active electrode while a neutral electrode contacts the patient to close the circuit. Used in hospital or clinic settings. Features an emergency stop button for patient safety. Output is controlled via the console interface. Benefits include pain relief, muscle spasm reduction, improved circulation, and muscle re-education. RF and EMS modes are mutually exclusive. Device performance is validated through electrical safety, EMC, and human tissue temperature elevation studies.

Clinical Evidence

Bench testing only. Included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and software validation. A human tissue temperature elevation study was conducted on three body parts across all operation modes and power settings to confirm the device's ability to maintain therapeutic skin temperatures.

Technological Characteristics

Cart-mounted console; 300kHz-1MHz RF frequency; 2-200Hz EMS frequency; monopolar/multipolar RF modes; biphasic symmetrical EMS waveform. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-6. Biocompatible materials per ISO 10993-1. Input: 100-240 VAC, 50-60Hz.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasms, increased local circulation, or temporary reduction in cellulite appearance (RF mode); and for prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, or maintenance/increase of range of motion (EMS mode). Contraindicated for simultaneous or sequential use of RF and EMS modes.

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

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 19, 2023

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

### Re: K230037

Trade/Device Name: Back 3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, IPF Dated: June 21, 2023 Received: June 2, 2023

### Dear Mr. 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 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

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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 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 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Mark Trumbore. The date of the signature is July 19, 2023, and the time is 13:35:27 -04:00.

Mark Trumbore, 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

510(k) Number (if known) K230037

Device Name BACK 3

Indications for Use (Describe)

The BACK 3 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 3 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 3 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 3 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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# Section 1.5

# 510(k) Summary

### Date : 04/11/2023

| 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: | BACK2 Massager, Radiofrequency Induced Heat therapy and<br>Electrostimulation device |
| 4. | Trade name : | BACK 3 |
| 5. | Classification: | Class II Medical Device |
| 6. | Device Product Codes: | PBX, IPF |

### Description:

The BACK 3 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.

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

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### Intended Use:

The BACK 3 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 3 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 3 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 3 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 3 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><br><b>BACK3 COLOR</b><br>Product codes: PBX | Daeyang Medical | K214090 (SWIMS America Corp) | RF technology (300kHz-1MHz) |
| <b>Secondary device</b><br>Evolve System with the<br>T3 Applicator<br>Product codes : PBX, GZJ, IPF | InMode Ltd. | K210877 | EMS technology signals |

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

The BACK 3 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 3 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 pain/ 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 3 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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| 510(k) Premarket Notification | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SWIMS America Corp | | | | | |
| K230037 | | | | | |
| Element of Comparison | 510(k) Device:<br>BACK 3 | 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 Product<br>Classification Codes | 21 CFR 878.4400 (PBX)<br>21 CFR 890.5850 (IPF) | 21 CFR 878.4400 (PBX) | 21 CFR 878.4400 (PBX)<br>21 CFR 882.5890 (GZJ)<br>21 CFR 890.5850 (IPF) | The BACK 3 device follows the same Product<br>codes as the two predicate devices: PBX, IPF.<br>However, BACK 3 does not use the code GZJ:<br>Transcutaneous electrical nerve stimulator for<br>pain relief. Therefore, BACK 3 does not have<br>the indications for use of the GZJ Product<br>Code. This does not raise new questions of<br>safety and effectiveness. | |
| Prescription/OTC | Prescription | Prescription | Prescription | Identical | |
| Indications for Use | The BACK 3 device employs RF<br>technology or EMS technology for<br>the treatment of selected medical<br>conditions.<br>PBX code: The BACK 3 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 3 massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite.<br>IPF code:<br>The BACK 3 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<br>reduction<br>in<br>the<br>appearance of cellulite. | The Evolve System with the T3<br>Applicator<br>employs<br>RF<br>EMS-TENS<br>technology<br>or<br>technology for the treatment of<br>selected medical conditions.<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>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<br>blood<br>local<br>circulation<br>*Muscle re-education<br>*Maintaining<br>increasing<br>or<br>range of motion | The BACK 3 device shares the same intended<br>for use as BACK3 COLOR and Evolve System<br>for the RF technology (PBX code).<br>Also, the BACK 3 device has less indications<br>for use than the secondary predicate device<br>Evolve System with the T3 Applicator for<br>EMS-TENS modes.<br>Therefore, the BACK 3 device does not have<br>new indications for use compared to the two<br>for<br>RF and<br>predicate<br>devices<br>EMS<br>technologies. This does not raise<br>new<br>questions of safety and effectiveness. | |
| | | 510(k) Premarket Notification | | | |
| | | SWIMS America Corp | | | |
| | | K230037 | | | |
| | The RF treatment mode and EMS<br>mode should not be used in<br>combination or sequentially. | | *Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis. | | |
| | | | GZJ code:<br>The T3 Applicator in TENS<br>mode is intended for:<br>*Symptomatic relief and<br>management of chronic,<br>intractable pain<br>*Post-surgical acute pain<br>*Post-trauma acute pain. | | |
| | | | The RF treatment mode and<br>EMS/TENS mode should not<br>be used in combination or<br>sequentially. | | |
| Environment Used | Hospital or Clinic setting | Hospital or Clinic setting | Hospital or Clinic setting | Identical | |
| Performance standards<br>(FDA recognized<br>consensus standards) | IEC 60601-1: General requirements<br>for basic safety and essential<br>performance<br>IEC 60601-1-2: General<br>requirements for basic safety and<br>essential performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements and<br>tests.<br>IEC 60601-2-10: particular<br>requirements for the Basic Safety<br>and Essential Performance of Nerve<br>and Muscle stimulators.<br>IEC 60601-1-6: General<br>requirements for basic safety and<br>essential performance -Collateral<br>standard: Usability. | IEC 60601-1: General requirements<br>for basic safety and essential<br>performance<br>IEC 60601-1-2: General<br>requirements for basic safety and<br>essential performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements and<br>tests.<br>IEC 60601-2-10: particular<br>requirements for the Basic Safety<br>and Essential Performance of Nerve<br>and Muscle stimulators.<br>IEC 60601-1-6: General<br>requirements for basic safety and<br>essential performance -Collateral<br>standard: Usability. | IEC 60601-1: General<br>requirements for basic safety<br>and essential performance<br>IEC 60601-1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral Standard:<br>Electromagnetic disturbances -<br>Requirements and tests.<br>IEC 60601-2-10: particular<br>requirements for the Basic<br>Safety and Essential<br>Performance of Nerve and<br>Muscle stimulators.<br>IEC 60601-1-6: General<br>requirements for basic safety<br>and essential performance -<br>Collateral standard: Usability. | The BACK 3 device complies to the same<br>performance standards as the two predicate<br>devices, except to<br>IEC 60601-2-2 as the Subject device is not<br>intended to be used in a surgical environment<br>nor in an emergency. Also, the BACK 3 device<br>is not a life supporting device. This does not<br>raise new questions of safety and effectiveness. | |
| 510(k) Premarket Notification<br>SWIMS America Corp<br>K230037 | | | EN IEC 60601-2-2 :Particular<br>requirements for the basic<br>safety and essential<br>performance of high-frequency<br>surgical equipment and high-<br>frequency surgical accessories. | | |
| Applicator Shapes | Square, rectangular and circular | Square, rectangular and circular | Rectangular…