RSHOCK

K220014 · Swims America Corp · PBX · Mar 1, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K220014
• Device Name: RSHOCK
• Applicant: Swims America Corp
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Mar 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

RSHOCK is a radiofrequency (RF) device providing topical heating via high-frequency sinusoidal current. System comprises a power console, LCD monitor, and resistive electrodes. Operation involves a monopolar mode where a fixed electrode contacts the patient and a therapist-manipulated handheld electrode completes the circuit. Device delivers 300kHz RF energy to elevate tissue temperature. Used in clinical settings by therapists to treat pain, muscle spasms, and improve local circulation, or for temporary cellulite reduction. Healthcare providers select treatment intensity via console controls. Benefits include non-invasive thermal therapy for musculoskeletal conditions and aesthetic improvement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included usability and risk management assessments, biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity), software validation, electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1).

Technological Characteristics

Console-based RF generator; 300kHz frequency; monopolar resistive mode; 100W max power; 0-3 intensity levels. Accessories include square and circular resistive electrodes. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Biocompatible tissue-contacting probes. User interface via LCD monitor and console controls.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasm treatment, 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

• Winback Back 3SE (K162828)

Submission Summary (Full Text)

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March 1, 2023

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

Re: K220014

Trade/Device Name: Rshock Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: January 30, 2023 Received: February 2, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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/9 description: The image shows a digital signature. The signature is for Mark Trumbore and the date is 2023.03.01. The time of the signature is 08:24:30 -05'00'.

On behalf of 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

510(k) Number (if known) K220014

Device Name RSHOCK

Indications for Use (Describe)

The RSHOCK 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 RSHOCK massage device 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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# Section 1.5

# 510(k) Summary

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# 510(k) Summary Pursuant to 21 CFR 807.92

### Date: 09/02/2022

| 1. | Submitted By: | SWIMS America Corp<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604<br>917-371-7388 |
|----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Matthieu COMMEAU<br>SWIMS America Corp, Managing Director<br>1133 Westchester Avenue Suite N 220<br>White Plains, NY 10604<br>917-371-7388<br>[e-mail] |
| 3. | Product: | RSHOCK<br>(21CFR§878.4400) Class II<br>RSHOCK<br>Product code PBX |
| 4. | Common/Trade Name: | Massager, Radiofrequency Induced Heat<br>RSHOCK |

#### Description:

The RSHOCK 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 power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz.

#### Intended Use:

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

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#### 510(k) Premarket Notification SWIMS America Corp K220014/S001

## Substantial Equivalence/Technological Characteristics:

The RSHOCK device is substantially equivalent to the Back 3SE device from Winback USA Corp which was cleared under premarket notification K162828. Both devices are consoles with electrode accessories capable of operation in monopolar mode of 300kHz radiofrequency.

Both devices operate in the same treatment range and feature intensity adjustments. 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.

The table below summarizes the equivalence of the devices.

| Element of Comparison | 510(k) Device:<br>RSHOCK | Predicate Device:<br>Winback Back 3SE<br>K162828 | Explanation of<br>Differences |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Regulation and Product<br>Classification Code | 21 CFR 878.4400<br>PBX | 21 CFR 878.4400<br>PBX | None |
| Indications for Use | The RSHOCK device is intended to<br>provide topical heating for the<br>purpose of elevating tissue<br>temperature for the treatment of<br>selected medical conditions such as<br>relief of pain, muscle<br>spasms, and increase in local<br>circulation.<br>The RSHOCK massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. | The Winback Back 3SE device is<br>intended to provide topical heating<br>for the purpose of elevating tissue<br>temperature for the treatment of<br>selected medical conditions such as<br>relief of pain, muscle<br>spasms, and increase in local<br>circulation.<br>The Winback Back 3SE massage<br>device is intended to provide a<br>temporary reduction in the<br>appearance of cellulite. | Identical |
| Massaging Hand piece | No | Yes | No significant<br>difference |
| Electrode Shapes | Square and circular | Square and circular | Identical |
| Infrared Light | No | No | Identical |
| Vacuum (suction) | No | No | Identical |
| Treatment Activation | Finger selection on console | Finger selection on console | Identical |
| RF Type | Unipolar | Multipolar/Unipolar | No significant<br>difference |
| RF Frequency | 300kHz | 300kHz – 1MHz | No significant<br>difference |
| Max RF Power | 100W | 300W | No significant<br>difference |
| Intensity Adjustment | 0-3 levels | 0-100% | Not the same scale<br>but the same values |
| Configuration | Console with accessories | Cart mounted console with<br>accessories | No significant<br>difference |
| Patient Safety Switch | Yes | Yes | Identical |

## Predicate Device Comparison Table

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#### 510(k) Premarket Notification SWIMS America Corp K220014/S001

### Summary of Testing:

The technological characteristics of the RSHOCK System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability.

The following testing has been conducted with satisfactory results:

- RSHOCK Usability and Risk Management: Usability and Risk Management assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
- . Biocompatibility: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity.
- . Software Assessment: Software features were assessed in accordance with FDA software validation guidelines. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
- . Electromagnetic Compatibility: EMC testing was done to evaluate emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
- . Electrical Safety: Full electrical safety testing was done in compliance with IEC 60601-1.

#### Conclusion:

The RSHOCK is substantially equivalent to the predicate devices operate in the same treatment range and voltage and feature intensity adjustments. Electrical safety and biocompatibility have been established for both devices.