Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical components and operational modes (RF therapy, frequency range) and does not mention any AI/ML capabilities. The performance study described is a tissue temperature elevation study, not an AI/ML model validation.

Therapeutic

Yes
The device is described as treating "selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation," and provides "therapeutic temperature on the surface of the human skin," indicating a therapeutic purpose.

Diagnostic

No
The "Intended Use / Indications for Use" section states the device is for topical heating to relieve pain, muscle spasms, and increase local circulation, as well as temporarily reduce the appearance of cellulite. These are therapeutic applications, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a power console, LCD monitor, and electrodes, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the BACK3 COLOR 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 involves direct interaction with the patient's body.
Device Description: The device generates high frequency sinusoidal current and uses electrodes applied to the patient's skin. This is a form of physical therapy or medical device used for treatment, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body. IVDs are designed to provide information about a person's health status based on the analysis of these samples.

In summary, the BACK3 COLOR is a therapeutic medical device that applies energy to the body for treatment, which is distinct from the function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BACK3 COLOR 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 BACK3 COLOR 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 BACK3 COLOR 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 capacitor resistive monopolar mode and a multipolar mode.

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

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)

Human being testing: a tissue temperature elevation study was conduct to demonstrate ability of all applicators of subject device to maintain therapeutic temperature on the surface of the human skin. The study was conduct on three different people on three body parts with all device operation modes and at the lowest and highest power settings. The skin and room temperatures were measured.

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.

K162828

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

11/1/2022

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

Re: K214090

Trade/Device Name: BACK3 COLOR Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: September 30, 2022 Received: October 3, 2022

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

2

Indications for Use

510(k) Number (if known) K214090

Device Name BACK3 COLOR

Indications for Use (Describe)

The BACK3 COLOR 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 BACK3 COLOR 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

510(k) Premarket Notification SWIMS America Corp K214090

510(k) Summary Pursuant to 21 CFR 807.92

Date: 10/31/2022

| 1. | Submitted By: | SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604 |
|----|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Mr. Matthieu COMMEAU,
Managing Director of SWIMS America Corp,
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
Phone: 917-371-7388
Email: mat@winback.com |
| 3. | Common Name: | Winback Back 3SE Massager, Radiofrequency Induced Heat |
| 4. | Trade Name: | BACK3 COLOR |
| 5. | Classification: | Class II |
| 6. | Device Product Code: | PBX |

Description:

The BACK3 COLOR 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 capacitor resistive monopolar mode and a multipolar mode.

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

Intended Use:

The BACK3 COLOR 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

4

510(k) Premarket Notification SWIMS America Corp K214090

Substantial Equivalence/Technological Characteristics:

The BACK3 COLOR device is substantially equivalent to the Back 3SE device from Winback USA Corp which was cleared under premarket notification K162828. 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.

The table below summarizes the equivalence of the devices.

| Element of Comparison | 510(k) Device:
BACK3 COLOR
K214090 | 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 BACK3 COLOR 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 BACK3 COLOR 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.

Predicate Device Comparison Table

5

510(k) Premarket Notification

	K214090
Accessories provided
with the device (diameter
of the electrodes-mm)	CET handpiece	CET Handpiece	Addition of some new
accessories which does
not impact the security
and the performance of
the subject device.
These accessories have
been added to facilitate
the treatment of the
therapist depending on
the area to be treated.
These accessories have
however the same
utility, the same
intended uses and the
associated modes are
identical to those of the
predicate (CET, RET...
etc).
	RET handpiece	RET Handpiece
	CET straight	CET electrodes (40, 60, 70mm)
	CET electrodes (40, 60, 70mm)	RET electrodes (40, 60,70mm)
	RET electrodes (40, 60, 70mm)	Active cable for CET electrodes
	Convex CET electrodes	Active cable for RET electrodes
	Thai CET Electrode	Neutral plate
	Convex RET Electrode	Safety switch
	Protect Ring	3-Polar applicator for Body
	Neutral plate	6- Polar applicator for Body
	Physio Blade and Connector	3- Polar applicator for Face
	RET Bracelet
	Capacitive Fix Pad
	Resistive Fix Pad
	Neutral Fix Pad
	Finger handpiece
	Flex Pack
	TECAR 6.0 Handpiece
	TECAR 6.0 Tip (M)
	3-Polar applicator for Body
	3-Polar applicator for Face
	Safety Switch
	Double Cable
	Active cable for CET electrodes
	Active cable for RET electrodes
Modes	CET	CET	Addition of some new
modes which does not
impact the security and
the performance of the
device. These modes
have been added to
facilitate the treatment
of the therapist
depending on the area
to be treated. These
modes have however
the same utility and the
same intended uses as
those of the predicate
(CET, RET, etc).
	RET	RET
	DEEP RET	DEEP CET
	DEEP CET	FACE 3-POLAR
	PULSE	BODY 3-POLAR
	FRACTAL	BODY 6-POLAR
	FACE 3-POLAR
	BODY 3-POLAR
			The FRACTAL mode is
only compatible with
the use of the accessory
TECAR 6.0.
Its frequency is the
same as the RET. This
mode has for aim to
deliver TECAR energy
			in fractional form which
is divided into several
heating points for a
focused and targeted
deep action.
Functions	MINI	LOWPULSE	Addition of some new
functions which does
	MEDIUM	CONTINUOUS	not impact the security
	BOOST	BOOST	SUPERPULSE	SUPERPULSE	not impact the security
SWAP	NORMAL	and the performance of
DYNAMIC	DYNAMIC	the device. These
	BOOST	modes have been added
		to facilitate the
		treatment of the
		therapist depending on
		the area to be treated.
		These modes have

6

510(k) Premarket Notification

SWIMS America Corp

K214090
			however the same
utility and the same
intended uses as those
of the predicate (CET,
RET, etc).

Change of name of
functions:
The name of the
functions has been
modified. However, the
functions are the same
as those of the
predicate.

7

510(k) Premarket Notification SWIMS America Corp K214090

Summary of Testing:

The technological characteristics of the BACK3 COLOR System has been verified based on assessments of electrical safety, performance, biocompatibility, software and usability.

The following testing has been conducted with satisfactory results:

BACK3 COLOR 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.
Human being testing : a tissue temperature elevation study was conduct to demonstrate ability of all applicators of subject device to maintain therapeutic temperature on the surface of the human skin. The study was conduct on three different people on three body parts with all device operation modes and at the lowest and highest power settings. The skin and room temperatures were measured.

Conclusion:

The BACK3 COLOR is substantially equivalent to the predicate device (K162828). 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.