Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device using RF and EMS technology with adjustable parameters, but there is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is intended for the treatment of selected medical conditions such as relief of pain, muscle spasms, increased local circulation, prevention or retardation of disuse atrophy, muscle re-education, and maintaining or increasing range of motion. These are therapeutic applications.

Diagnostic

No

The device description focuses on its therapeutic functions (RF technology for topical heating and EMS technology for muscle-related conditions) rather than diagnostic capabilities. There is no mention of the device being used to identify, measure, or analyze medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a power console, LCD monitor, electrodes, and the generation of RF and EMS signals, indicating it is a physical device with embedded technology, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the BACK 3 device is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use of the BACK 3 device is for therapeutic purposes, specifically using RF and EMS technology to treat medical conditions like pain, muscle spasms, cellulite, and muscle atrophy. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The device description details the technology used (RF and EMS) and how it interacts with the patient's body through electrodes. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD-related terms: The document does not contain any terms commonly associated with IVD devices, such as "specimen," "assay," "reagent," "analyzer," "diagnosis," or "screening."

The BACK 3 device is clearly described as a therapeutic device that applies energy to the body for treatment, not for analyzing samples to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

PBX, IPF

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

All body, external part except eyes, mouth, heart, mucosa parts and brain area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital or Clinic setting

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 following testing has been conducted with satisfactory results:

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 intracttaneous 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 electromages 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 conducted to demonstrate ability of albiet device to maintain therapeutic temperature on the human skin. The study was conduct 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.

K214090, K210877

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

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 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

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,

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

2

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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3

Section 1.5

510(k) Summary

Date : 04/11/2023

| 1. | Submitted By: | SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
Tel. 917-371-7388 |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person : | Mr. Matthieu COMMEAU
Managing Director of SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
Tel. 917-371-7388
Email: mat@winback.com |
| 3. | Common Name: | BACK2 Massager, Radiofrequency Induced Heat therapy and
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.

4

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
Primary device
BACK3 COLOR
Product codes: PBX	Daeyang Medical	K214090 (SWIMS America Corp)	RF technology (300kHz-1MHz)
Secondary device
Evolve System with the
T3 Applicator
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

5

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

6

510(k) Premarket Notification
SWIMS America Corp
K230037
Element of Comparison	510(k) Device:
BACK 3	Primary Predicate Device:
BACK3 COLOR
K214090	Secondary Predicate Device:
Evolve System with the T3
Applicator
K210877	Explanation of Differences
Regulation and Product
Classification Codes	21 CFR 878.4400 (PBX)
21 CFR 890.5850 (IPF)	21 CFR 878.4400 (PBX)	21 CFR 878.4400 (PBX)
21 CFR 882.5890 (GZJ)
21 CFR 890.5850 (IPF)	The BACK 3 device follows the same Product
codes as the two predicate devices: PBX, IPF.
However, BACK 3 does not use the code GZJ:
Transcutaneous electrical nerve stimulator for
pain relief. Therefore, BACK 3 does not have
the indications for use of the GZJ Product
Code. This does not raise new questions of
safety and effectiveness.
Prescription/OTC	Prescription	Prescription	Prescription	Identical
Indications for Use	The BACK 3 device employs RF
technology or EMS technology for
the treatment of selected medical
conditions.
PBX code: 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.
IPF code:
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.	PBX code: 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 Evolve System with the T3
Applicator
employs
RF
EMS-TENS
technology
or
technology for the treatment of
selected medical conditions.
PBX code:
The T3 Applicator in RF mode
is intended for the temporary
relief of minor muscles aches
and pain, temporary relief of
muscle spasm, and temporary
improvement of local blood
circulation.
IPF code:
The T3 Applicator in EMS
mode is intended for:
*Relaxation of muscle spasms
*Prevention or retardation of
disuse atrophy
*Increasing
blood
local
circulation
*Muscle re-education
*Maintaining
increasing
or
range of motion	The BACK 3 device shares the same intended
for use as BACK3 COLOR and Evolve System
for the RF technology (PBX code).
Also, the BACK 3 device has less indications
for use than the secondary predicate device
Evolve System with the T3 Applicator for
EMS-TENS modes.
Therefore, the BACK 3 device does not have
new indications for use compared to the two
for
RF and
predicate
devices
EMS
technologies. This does not raise
new
questions of safety and effectiveness.
		510(k) Premarket Notification
		SWIMS America Corp
		K230037
	The RF treatment mode and EMS
mode should not be used in
combination or sequentially.		*Immediate post-surgical
stimulation of calf muscles to
prevent venous thrombosis.
			GZJ code:
The T3 Applicator in TENS
mode is intended for:
*Symptomatic relief 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 combination or
sequentially.
Environment Used	Hospital or Clinic setting	Hospital or Clinic setting	Hospital or Clinic setting	Identical
Performance standards
(FDA recognized
consensus standards)	IEC 60601-1: General requirements
for basic safety and essential
performance
IEC 60601-1-2: General
requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic
disturbances - Requirements and
tests.
IEC 60601-2-10: particular
requirements for the Basic Safety
and Essential Performance of Nerve
and Muscle stimulators.
IEC 60601-1-6: General
requirements for basic safety and
essential performance -Collateral
standard: Usability.	IEC 60601-1: General requirements
for basic safety and essential
performance
IEC 60601-1-2: General
requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic
disturbances - Requirements and
tests.
IEC 60601-2-10: particular
requirements for the Basic Safety
and Essential Performance of Nerve
and Muscle stimulators.
IEC 60601-1-6: General
requirements for basic safety and
essential performance -Collateral
standard: Usability.	IEC 60601-1: General
requirements for basic safety
and essential performance
IEC 60601-1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances -
Requirements and tests.
IEC 60601-2-10: particular
requirements for the Basic
Safety and Essential
Performance of Nerve and
Muscle stimulators.
IEC 60601-1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability.	The BACK 3 device complies to the same
performance standards as the two predicate
devices, except to
IEC 60601-2-2 as the Subject device is not
intended to be used in a surgical environment
nor in an emergency. Also, the BACK 3 device
is not a life supporting device. This does not
raise new questions of safety and effectiveness.
510(k) Premarket Notification
SWIMS America Corp
K230037			EN IEC 60601-2-2 :Particular
requirements for the basic
safety and essential
performance of high-frequency
surgical equipment and high-
frequency surgical accessories.
Applicator Shapes	Square, rectangular and circular	Square, rectangular and circular	Rectangular	Identical to the primary predicate device.

Difference in shape compared to the secondary
predicate device. However, this difference
does not raise any new questions of safety and
effectiveness compared to the secondary
predicate device. The biocompatibility testing
and usability attest of the safety of these
accessories. | |
| Infrared Light | No | No | No | Identical | |
| Vacuum (suction) | No | No | No | Identical | |
| Applied energy | RF/EMS | RF | RF/EMS-TENS | The BACK 3 device has the same RF
technological characteristics as the primary
predicate device.

The subject device can apply the same energy
EMS as the secondary predicate device.
However, the BACK 3 does not use GZJ as the
secondary predicate device does. So, the
subject device does not have TENS energy.
This does not raise new questions of safety and
effectiveness. | |
| Power source | Main line frequency (nominal): 50-
60Hz.
Input Voltage (nominal): 100-
240VAC.
Input current (rms): 1.25Aac
@240Vac and 3Aac @ 100Vac. | Main line frequency (nominal): 50-
60Hz.
Input Voltage (nominal): 100-
240VAC.
Input current (rms): 1.25Aac
@240Vac and 3Aac @ 100Vac. | Main line frequency (nominal):
50-60Hz.
Input Voltage (nominal): 100-
240VAC.
Input current (rms): 4A. | Power source characteristics are identical to
the primary predicate device.

The power source characteristics are different
to those of the secondary predicate device. The
main line frequency and input voltage are
similar, except for the input current. However,
this difference does not raise new safety and
effectiveness questions as electrical safety
testing has been performed following state of
the art standards. | |
| RF Type | Multipolar/Unipolar | Multipolar/Unipolar | Multipolar/Unipolar | Identical | |
| 510(k) Premarket Notification | | | | | |
| SWIMS America Corp
K230037 | | | | | |
| RF Frequency | 300kHz – 1MHz | 300kHz – 1MHz | 1MHz | Identical to the Primary predicate device for
RF technology.
The RF frequency of the secondary device falls
within range of the subject device.
This difference does not raise any new
questions of safety and effectiveness comparec
to the secondary predicate device. | |
| Maximum RF output
Power | 300W | 300W | 75W | Identical to the primary predicate device.
Different from the secondary predicate device.
This difference does not raise new questions of
safety and effectiveness. RF output power has
already been cleared with the primary
predicate device. | |
| Electrical type | Type BF | Type BF | Type BF | Identical | |
| EMS output
specifications;
waveform | Biphasic with symmetrical waveform | N.A | Symmetrical
Biphasic waveform | Identical | |
| EMS frequency | 2 to 200Hz | N.A | 3 to 200 Hz | Not identical.
The EMS frequency range of the subject
device has minor difference to the secondary
predicate device.
This difference does not raise any new
questions of safety and effectiveness compared
to the secondary predicate device.
This characteristic does not apply to the
primary predicate device. | |
| Patient Leakage
Current -Normal
Condition (uA) |