(420 days)
Not Found
No
The device description and performance studies focus on electrical safety, performance, biocompatibility, software, and usability of a radiofrequency therapy device. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as treating medical conditions such as pain, muscle spasms, and poor circulation, which are therapeutic applications.
No
The device is described as providing "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, not diagnostic, purposes. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description explicitly states it consists of a power console, LCD monitor, and accessories including resistive electrodes, indicating it is a hardware device that utilizes electrical current for therapy.
Based on the provided information, the RSHOCK 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 and massage for therapeutic purposes (pain relief, muscle spasms, circulation, cellulite reduction). This is a physical therapy/treatment application, not a diagnostic one.
- Device Description: The description details a device that generates and applies electrical current to the patient's body. This is a therapeutic mechanism, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RSHOCK device does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
Section 1.5
510(k) Summary
4
510(k) Summary Pursuant to 21 CFR 807.92
Date: 09/02/2022
| 1. | Submitted By: | SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
917-371-7388 |
|----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Matthieu COMMEAU
SWIMS America Corp, Managing Director
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
917-371-7388
mat@winback.com |
| 3. | Product: | RSHOCK
(21CFR§878.4400) Class II
RSHOCK
Product code PBX |
| 4. | Common/Trade Name: | Massager, Radiofrequency Induced Heat
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.
5
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:
RSHOCK | Predicate Device:
Winback Back 3SE
K162828 | Explanation of
Differences |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Regulation and Product
Classification Code | 21 CFR 878.4400
PBX | 21 CFR 878.4400
PBX | None |
| Indications for 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. | The Winback Back 3SE 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 Winback Back 3SE massage
device is intended to provide a
temporary reduction in the
appearance of cellulite. | Identical |
| Massaging Hand piece | No | Yes | No significant
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
difference |
| RF Frequency | 300kHz | 300kHz – 1MHz | No significant
difference |
| Max RF Power | 100W | 300W | No significant
difference |
| Intensity Adjustment | 0-3 levels | 0-100% | Not the same scale
but the same values |
| Configuration | Console with accessories | Cart mounted console with
accessories | No significant
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.