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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "BACK 3" medical device. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and various types of performance testing.

However, the document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) and then prove the device meets those criteria through a test set. This document is a regulatory submission for a physical therapy device that uses RF and EMS technology, not an AI/algorithm-based diagnostic device. Therefore, a study demonstrating performance against a fixed set of accuracy metrics on a test set (like for an imaging AI) is not applicable in the way queried.

The "studies" mentioned are primarily non-clinical performance tests proving the device functions as intended and meets safety standards, rather than clinical efficacy studies or diagnostic accuracy studies.

Here's a breakdown of what can be extracted, and what cannot be derived from the provided text based on your request:

What can be extracted:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria here are based on meeting safety and performance standards equivalent to the predicate devices, rather than specific accuracy metrics like sensitivity or specificity. No numerical performance metrics for diagnostic accuracy are provided, as this is not a diagnostic device.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety (IEC 60601-1)	Full electrical safety testing done in compliance. Patient leakage <50uA (normal), <300uA (single fault).
Electromagnetic Compatibility (IEC 60601-1-2)	EMC testing done to evaluate emissions and immunity to electromages.
Nerve and Muscle Stimulators Safety (IEC 60601-2-10)	Compliance established.
Biocompatibility (ISO 10993-1)	Samples of tissue contacting probes tested for cytotoxicity, sensitization, and intracutaneous reactivity, and found to comply.
Software Validation (FDA guidelines)	Software features assessed. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
Usability and Risk Management	Usability and Risk Management assessments done using worse-case assumptions to verify user interface, safety features, and satisfactory performance.
RF Heating Performance (Maintaining Therapeutic Temperature)	Human being testing conducted to demonstrate ability to maintain therapeutic temperature (38-42°C) on human skin in three body parts with all device operation modes and at lowest/highest power settings.
RF Frequency (300kHz - 1MHz)	Device operates within this range, identical to primary predicate.
Maximum RF Output Power (300W)	Device achieves this, identical to primary predicate.
EMS Frequency (2-200Hz)	Device operates within this range, minor difference with secondary predicate (3-200Hz) but still considered equivalent.
Patient Leakage Current (EMS) - Normal Condition (<100uA)	Device performance: <50uA.
Patient Leakage Current (EMS) - Single Fault Condition (<300uA)	Device performance: <300uA.
EMS Biphasic Symmetrical Waveform	Device provides this.
Net Charge @ 500 ohms (microC/pulse) for EMS (0)	Device performance: 0.
Max Power Density for EMS (below 22.2 (mW/cm2) from the predicate)	Device performance: 29.6 (mW/cm2), which is higher but stated to be "under the limit according to Section 3 of Attachment II (Output Waveforms) of FDA's Powered Muscle Stimulator Guidance".
Burst Mode for EMS (Pulses per burst, Bursts per second, Burst duration, Duty Cycle)	Pulses per burst: 2-200 (vs 3-200 for predicate). Bursts per second: 1 (identical). Burst duration: 5 sec (vs 1-60 sec for predicate). Duty Cycle: Time on/off (identical). All differences are deemed to not raise new safety/effectiveness questions and meet guidance for muscle stimulation (5 sec on, 1 sec off).

2. Sample size used for the test set and the data provenance:

Test Set (Human Being Testing for RF temperature elevation): "The study was conducted on three body parts..." The sample size is not explicitly stated but implies a very small number, possibly just one subject given the phrasing "on the human skin" not "on human subjects." This is likely a preliminary engineering verification test, not a clinical trial.
Data Provenance: Not specified, but generally, for such a non-clinical test, it would be internal lab data (e.g., from the manufacturer or a contract lab). It is retrospective in the context of the 510(k) submission, as the data was collected prior to the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a non-diagnostic device. The "ground truth" for the human being testing was the measured tissue temperature.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for this type of non-clinical, non-diagnostic device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device provides RF and EMS therapy; it's not an algorithm that standalone performs a diagnostic task. The device's "standalone" performance is its ability to deliver the specified energy within safety limits.

7. The type of ground truth used:

For the "human being testing," the ground truth was measured tissue temperature.
For other performance tests (electrical safety, EMC, etc.), the ground truth was defined by compliance with recognized standards (e.g., IEC 60601-1).

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a "training set" in the typical ML sense. Its design and validation are based on engineering principles and compliance with established standards, building upon prior predicate devices.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set."

Summary of the "Study" (Non-Clinical Performance Testing):

The document describes various non-clinical performance tests rather than a single "study" proving diagnostic accuracy. These tests include:

Usability and Risk Management Assessments: Verified user interface, safety, and performance.
Biocompatibility Testing: On tissue-contacting probes for cytotoxicity, sensitization, and intracutaneous reactivity.
Software Assessment: Validated against FDA guidelines, including requirements, hazard analysis, and testing.
Electromagnetic Compatibility (EMC) Testing: Evaluated emissions and immunity.
Electrical Safety Testing: Compliance with IEC 60601-1.
Human Being Testing (Temperature Elevation): Conducted to demonstrate the device's ability to maintain a therapeutic temperature (38-42°C) on human skin across "three body parts" using all modes and power settings. This is the closest to a "study" involving humans, but it's a performance verification rather than a clinical trial for efficacy or diagnostic performance.

The overarching "acceptance criteria" for this 510(k) submission are that the device meets the safety, performance, and design standards of its legally marketed predicate devices and established consensus standards (e.g., IEC 60601-1), and that any differences do not raise new questions of safety or effectiveness.

Summary

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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 (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

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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 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 Corp1133 Westchester Avenue Suite N 220White Plains, NY 10604Tel. 917-371-7388
2.	Contact Person :	Mr. Matthieu COMMEAUManaging Director of SWIMS America Corp1133 Westchester Avenue Suite N 220White Plains, NY 10604Tel. 917-371-7388Email: mat@winback.com
3.	Common Name:	BACK2 Massager, Radiofrequency Induced Heat therapy andElectrostimulation device
4.	Trade name :	BACK 3
5.	Classification:	Class II Medical Device
6.	Device Product Codes:	PBX, IPF

Description:

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 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 deviceBACK3 COLORProduct codes: PBX	Daeyang Medical	K214090 (SWIMS America Corp)	RF technology (300kHz-1MHz)
Secondary deviceEvolve System with theT3 ApplicatorProduct 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:BACK 3	Primary Predicate Device:BACK3 COLORK214090	Secondary Predicate Device:Evolve System with the T3ApplicatorK210877	Explanation of Differences
Regulation and ProductClassification 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 Productcodes as the two predicate devices: PBX, IPF.However, BACK 3 does not use the code GZJ:Transcutaneous electrical nerve stimulator forpain relief. Therefore, BACK 3 does not havethe indications for use of the GZJ ProductCode. This does not raise new questions ofsafety and effectiveness.
Prescription/OTC	Prescription	Prescription	Prescription	Identical
Indications for Use	The BACK 3 device employs RFtechnology or EMS technology forthe treatment of selected medicalconditions.PBX code: The BACK 3 device in RFmode is intended to provide topicalheating for the purpose of elevatingtissue temperature for the treatment ofselected medical conditions such asrelief of pain, muscle spasms, andincrease in local circulation.The BACK 3 massage device isintended to provide a temporaryreduction in the appearance ofcellulite.IPF code:The BACK 3 device in EMS mode isintended for:Prevention or retardation of disuseatrophyIncreasing local blood circulationMuscle re-educationMaintaining or increasing range ofmotion.	PBX code: The BACK3 COLORdevice is intended to provide topicalheating for the purpose of elevatingtissue temperature for the treatmentof selected medical conditions suchas relief of pain, muscle spasms, andincrease in local circulation.The BACK3 COLOR massagedevice is intended to provide atemporaryreductionintheappearance of cellulite.	The Evolve System with the T3ApplicatoremploysRFEMS-TENStechnologyortechnology for the treatment ofselected medical conditions.PBX code:The T3 Applicator in RF modeis intended for the temporaryrelief of minor muscles achesand pain, temporary relief ofmuscle spasm, and temporaryimprovement of local bloodcirculation.IPF code:The T3 Applicator in EMSmode is intended for:Relaxation of muscle spasmsPrevention or retardation ofdisuse atrophyIncreasingbloodlocalcirculationMuscle re-education*Maintainingincreasingorrange of motion	The BACK 3 device shares the same intendedfor use as BACK3 COLOR and Evolve Systemfor the RF technology (PBX code).Also, the BACK 3 device has less indicationsfor use than the secondary predicate deviceEvolve System with the T3 Applicator forEMS-TENS modes.Therefore, the BACK 3 device does not havenew indications for use compared to the twoforRF andpredicatedevicesEMStechnologies. This does not raisenewquestions of safety and effectiveness.
		510(k) Premarket Notification
		SWIMS America Corp
		K230037
	The RF treatment mode and EMSmode should not be used incombination or sequentially.		*Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis.
			GZJ code:The T3 Applicator in TENSmode is intended for:Symptomatic relief andmanagement of chronic,intractable painPost-surgical acute pain*Post-trauma acute pain.
			The RF treatment mode andEMS/TENS mode should notbe used in combination orsequentially.
Environment Used	Hospital or Clinic setting	Hospital or Clinic setting	Hospital or Clinic setting	Identical
Performance standards(FDA recognizedconsensus standards)	IEC 60601-1: General requirementsfor basic safety and essentialperformanceIEC 60601-1-2: Generalrequirements for basic safety andessential performance - CollateralStandard: Electromagneticdisturbances - Requirements andtests.IEC 60601-2-10: particularrequirements for the Basic Safetyand Essential Performance of Nerveand Muscle stimulators.IEC 60601-1-6: Generalrequirements for basic safety andessential performance -Collateralstandard: Usability.	IEC 60601-1: General requirementsfor basic safety and essentialperformanceIEC 60601-1-2: Generalrequirements for basic safety andessential performance - CollateralStandard: Electromagneticdisturbances - Requirements andtests.IEC 60601-2-10: particularrequirements for the Basic Safetyand Essential Performance of Nerveand Muscle stimulators.IEC 60601-1-6: Generalrequirements for basic safety andessential performance -Collateralstandard: Usability.	IEC 60601-1: Generalrequirements for basic safetyand essential performanceIEC 60601-1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances -Requirements and tests.IEC 60601-2-10: particularrequirements for the BasicSafety and EssentialPerformance of Nerve andMuscle stimulators.IEC 60601-1-6: Generalrequirements for basic safetyand essential performance -Collateral standard: Usability.	The BACK 3 device complies to the sameperformance standards as the two predicatedevices, except toIEC 60601-2-2 as the Subject device is notintended to be used in a surgical environmentnor in an emergency. Also, the BACK 3 deviceis not a life supporting device. This does notraise new questions of safety and effectiveness.
510(k) Premarket NotificationSWIMS America CorpK230037			EN IEC 60601-2-2 :Particularrequirements for the basicsafety and essentialperformance of high-frequencysurgical 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 secondarypredicate device. However, this differencedoes not raise any new questions of safety andeffectiveness compared to the secondarypredicate device. The biocompatibility testingand usability attest of the safety of theseaccessories.
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 RFtechnological characteristics as the primarypredicate device.The subject device can apply the same energyEMS as the secondary predicate device.However, the BACK 3 does not use GZJ as thesecondary predicate device does. So, thesubject device does not have TENS energy.This does not raise new questions of safety andeffectiveness.
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 tothe primary predicate device.The power source characteristics are differentto those of the secondary predicate device. Themain line frequency and input voltage aresimilar, except for the input current. However,this difference does not raise new safety andeffectiveness questions as electrical safetytesting has been performed following state ofthe art standards.
RF Type	Multipolar/Unipolar	Multipolar/Unipolar	Multipolar/Unipolar	Identical
510(k) Premarket Notification
SWIMS America CorpK230037
RF Frequency	300kHz – 1MHz	300kHz – 1MHz	1MHz	Identical to the Primary predicate device forRF technology.The RF frequency of the secondary device fallswithin range of the subject device.This difference does not raise any newquestions of safety and effectiveness comparecto the secondary predicate device.
Maximum RF outputPower	300W	300W	75W	Identical to the primary predicate device.Different from the secondary predicate device.This difference does not raise new questions ofsafety and effectiveness. RF output power hasalready been cleared with the primarypredicate device.
Electrical type	Type BF	Type BF	Type BF	Identical
EMS outputspecifications;waveform	Biphasic with symmetrical waveform	N.A	SymmetricalBiphasic waveform	Identical
EMS frequency	2 to 200Hz	N.A	3 to 200 Hz	Not identical.The EMS frequency range of the subjectdevice has minor difference to the secondarypredicate device.This difference does not raise any newquestions of safety and effectiveness comparedto the secondary predicate device.This characteristic does not apply to theprimary predicate device.
Patient LeakageCurrent -NormalCondition (uA)	<50uA patient leakage	N.A	<100uA patient leakage	Not identical.Patient leakage current range has minordifference to the patient leakage current rangeof the secondary predicate device.This difference does not raise any newquestions of safety and effectiveness comparedto the secondary predicate device.This characteristic does not apply to theprimary predicate device.
Patient LeakageCurrent-Single Faultcondition (uA)	<300uA line leakage	N.A	<300uA line leakage	Identical to the secondary predicate device.This characteristic does not apply to theprimary predicate device.
Number of Outputchannels	2	3	6	Not identical.The BACK 3 device has less output channelsthan the predicate devices, this does not raisenew questions of safety and effectiveness.
Console	Console, including a power supplyunit, controller, and user interfaceincluding a LCD touch screen.	Console, including a power supplyunit, controller, and user interfaceincluding a LCD touch screen.	Console, including a powersupply unit, controller, and userinterface including a LCD touchscreen.	Identical
Software control	Yes	Yes	Yes	Identical
Indicator Display	On/Off statusVoltage/current level	On/Off statusVoltage/current level	On/Off statusVoltage/current level	Identical
Battery	No	No	No	Identical
Timer Range (minutes)	0-60 (minutes)	0-60 (minutes)	0-60 (minutes)	Identical
Accessories providedwith the device (diameterof the electrodes inmillimeters)	TECAR X handset	/	T3 Applicator:Up to 6 units connected to theconsole via 6 designed cablesand 6 designated connectionport.Size of the applicator : 67.3mmL x 54.3mm D	Comparison with the primary predicate device:Addition/deletion of some accessories for thesubject device compared to the primarypredicate device: additional accessoriesprovided with the subject device are indicatedin blue.The addition of these accessories does not raisenew questions of safety and effectiveness ofthe subject device.These accessories have been added to facilitatethe treatment of the therapist depending on thearea to be treated.These accessories have however the sameutility, the same intended use as the primarypredicate device and the associated modes areidentical to those of the predicate (CET, RET,...etc.).Change of some accessory denominations:Some accessories have a new name but stay thesame as for the predicate (same design, sameintended use, same contact material).
	RET Bracelet	RET Bracelet
	Neutral return plate	Neutral plate
	Neutral handle	/
	RET electrodes (40, 60, 70mm)	RET electrodes (40, 60, 70mm)
	Convex RET electrodes (25, 40mm)	Convex RET electrode (25mm)
	CET electrodes (40, 60, 70mm)	CET electrodes (40, 60, 70mm)
	Convex CET electrodes (35, 40,60mm)	Convex CET electrode (35, 60mm)
	Hi-RET electrode	TECAR 6.0 HandpieceTECAR 6.0 Tip (M)
	Multipolar electrode S	3-Polar applicator Face
	Multipolar electrode L	3-Polar applicator Body
	RET Fixed Pad	Resistive Fix Pad
	Neutral Fixed Pad	Neutral Fix Pad
	TECAR mobile handle	/
	Neutral TECAR mobile handle	/
	Neutral generic cable	/
		SWIMS America Corp
	RET/CET generic cable	K230037Active cable for CET electrodes		Not all the listed accessories of the subjectdevice can be connected as the same time, as
		Active cable for RET electrodes		device can be connected as the same time, asthere are only 2 channels on the device. It is thesame for the primary predicate device.
	RET snap cable	/		Comparison with the secondary predicatedevice:
	CET Extender	/
	RET Extender	/
	Emergency stop button	Safety Switch
	Power cord	Alimentation cable		device:The secondary predicate device has moreaccessories connected during the treatment. Itcan have up to 6 accessories for RF or EMS
	Essential conductive Cream	/
	Fascia Blade	Physio Blade and Connector
	TECAR Essential CET	CET handpiece
	TECAR Essential RET	RET handpiece		technology.Due to this configuration, it is less risky for the
	/	Thai CET Electrode (70mm)
	/	Protect Ring (50, 70, 80mm)
	/	Capacitive Fix Pad		patient to be treated with less pieces. Thedifference doesn't raise new questions of safetyand effectiveness.
	/	Flex Pack
	Finger Handpiece	Finger Handpiece
	Double Cable	Double Cable
	/	CET straight
	/	Flex Pack
Modes	CET SOFT	CET	RF
	CET DEEP	CET DEEP
	RET	RET		Comparison with the primary predicate device:Change of some Mode's names: some modeshave a new name but are the same (same
	RET + Hi-TENS	DEEP RET		intended use and frequencies).This difference does not raise new questions ofsafety and effectiveness.The Hi-EMS mode does not apply to theprimary predicate device.Comparison with the secondary predicatedevice:Both have the EMS mode. The only differenceis the marketing name of it. Electrical safetyand EMC testing have been performed for thesubject device. This difference does not raisenew questions of safety and effectiveness.
	Hi-TENS	PULSE
	MIX	FOCUS 3-POLARBODY 3-POLAR
SWIMS America Corp
K230037
		FRACTAL
	Hi-EMS	/	EMS
Functions	LOW	MINI	N.A	The names of the functions are the same asthose of the primary predicate device, exceptfor LOW function; The MINI function wasrenamed by LOW. However, the technicalcharacteristics of that LOW function areidentical to those of the MINI function.
	MEDIUM	MEDIUM
	BOOST	BOOST
	DYNAMIC	DYNAMIC
	SWAP	SWAP
	STATIC	STATIC
Design	The BACK 3 device consists of anAC/DC power supply unit, controller,2 RF generators and user interfaceincluding an LCD touch screen.The delivery of the RF/electricalenergy is controlled by a On/Offbutton positioned on the front panel.The system supports the followingcomponents:• LCD display touch screen• Audio loudspeaker• 100-240 VAC powersupply• Controller (GMU card)• 2 RF generatorsThe system operates while connectedto the accessories (electrodes) in RFmode or in EMS mode.	The BACK3 COLOR consists of anAC/DC power supply unit,controller, 2 RF generators and userinterface including an LCD touchscreen.The delivery of the RF is controlledby a On/Off button positioned on thefront panel.The system supports the followingcomponents:• LCD display touch screen• Audio loudspeaker• 100-240 VAC powersupply• Controller (GMU card)• 2 RF generatorsThe system operates whileconnected to the accessories(electrodes) in RF mode.	The EVOLVE system with T3Applicator consists of anAC/DC power supply unit,controller, 2 RF generators anduser interface including an LCDtouch screen.The delivery of theRF/electrical energy iscontrolled by a Start/Stopbutton positioned on the frontpanel.The system supports thefollowing components:• LCD display touchscreen• Audio loudspeaker• 100-240V• Controller• 2 RF generatorsThe system operates whileconnected to the applicators inRF mode or in EMS-TENSmode.	The subject device does not have the samedimensions and design than the predicatedevices.However, the screen of the BACK 3 device hasthe same size as the cleared device BACK 3COLOR.Finger selection on screen for the threedevices.However, the difference doesn't raise newquestions of safety and effectiveness.
		510(k) Premarket Notification
		SWIMS America Corp
		K230037
Dimension console(height x width x depth)in millimeters	336.6x353.1x161.3	148x306x358	100x460x460	Not identical.However, the difference doesn't raise newquestions of safety and effectiveness.The devices are not supposed to be moved.
Weight (kg)	4 kg	5 kg	33 kg	Not identical.The subject device is less heavy than thepredicate devices. That difference does notgenerate a safety and effectiveness issue.
Target temperatures	38-42°C	38-42°C	NA	Identical to the primary predicate device.
Treatment areas	All body, external part except eyes,mouth, heart, mucosa parts and brainarea	All body, external part except eyes,mouth, heart, mucosa parts and brainarea	Body parts requiring treatmentas specified in the indication foruse	Identical
Safety features	Emergency stop button	Emergency stop button	System in STOP state level at60 minutes.	Identical
Sterility	N.A	N.A	N.A	N.A
EMS Output Mode
Waveform	Biphasic with symmetrical waveform	N.A	SymmetricalBiphasic waveform	Identical
Shape	Sinusoidal	N.A	Rectangular	Not identical.The subject device and the secondarypredicate device are capable of musclestimulation.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new question ofsafety and effectiveness.This characteristic does not apply to theprimary predicate device.
510(k) Premarket NotificationSWIMS America CorpK230037
Maximum OutputVoltage (Vpeak)(+/-10%)	43.1 V @ 500 Ω64.0 V @ 2 k Ω73.2 V @ 10 k Ω	N.A	30 V @ 500 Ω54 V @ 2 k Ω54 V @ 10 k Ω	Not identical.The subject device provides a highermaximum output voltage than the secondarypredicate device.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
Maximum OutputCurrent (mA)(+/- 10%)	29.0 mA @ 500 Ω11.0 mA @ 2 k Ω5.0 mA @ 10 k Ω	N.A	60 mA@ 500 Ω27 mA @ 2 k Ω5.4 mA @ 10 k Ω	Not identical.The subject device provides a lower maximumoutput current than the secondary predicatedevice.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
Pulse Width (µsec)	Radial mode: 250µsecFocal mode : 250µsec	N.A	20 to 400µsec	Not identical.Radial mode:The pulse width of the subject device is withinthe range of the pulse width of the secondarypredicate device.This difference does not raise any newquestions of safety and effectiveness comparedto the secondary predicate device.This characteristic does not apply to theprimary predicate device.Focal mode:
		K230037
				The pulse width of the subject device is withinthe range of the pulse width of the secondarypredicate device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
Frequency (Hz)	2 to 200Hz	N.A	3 to 200 Hz	Not identical.The EMS frequency range of the subjectdevice has minor difference to the secondarypredicate device.This difference does not raise any newquestions of safety and effectiveness comparedto the secondary predicate device.This characteristic does not apply to theprimary predicate device.
Net Charge @ 500 ohms(microC/pulse)	0	N.A	0	Identical to the secondary predicate device.This characteristic does not apply to theprimary predicate device.
Maximum PhaseCharge, (microC)	N.A	N.A	24 microC @ 500 Ω	N/A
Maximum CurrentDensity (RMS),(mA/cm²)	1.0 (mA/cm²)Surface = 12.6cm²	N.A	0.74 (mA/cm²)Surface = 6.46cm²	Not identical.The subject device provides a highermaximum current density than the secondarypredicate device.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
510(k) Premarket Notification
SWIMS America Corp
K230037
Maximum PowerDensity, (mW/cm²)(Using smallestelectrode conductivesurface area)	29.6 (mW/cm²)	N.A	22.2 (mW/cm²)	Not identical.The subject device provides a highermaximum power density than the secondarypredicate device.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.Moreover, the maximum power density isunder the limit according to Section 3 ofAttachment II (Output Waveforms) of FDA'sPowered Muscle Stimulator Guidance(https://www.fda.gov/media/71804/download)
510(k) Premarket Notification
SWIMS America CorpK230037
Burst Mode (i.e., pulsetrains)a. Pulses per burstb. Bursts per secondc. Burst duration(seconds)d. Duty Cycle [Line (b)x Line (c)]	Yes,a. 2-200b. 1c. 5 secd. Time on/off	N.A	Yes,a. 3-200b. 1c. 1-60 secd. Time on/off	Not identical.Pulses per burst:The subject device has minor difference inpulses per bust range compared to thesecondary predicate device. This differencedoes not raise any additional questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.Burst duration:The subject device has a different burstduration than the secondary predicate device.However, the burst duration of the subjectdevice does not fall outside of the burstduration scope of the secondary predicatedevice.Electrical safety testing and EMC testing havebeen performed for the subject device.Usability and risk analysis have also beenperformed to support proof of safety andeffectiveness of the subject device.This difference does not raise new questions ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.Moreover, according to Section 3 ofAttachment II (Output Waveforms) of FDA'sPowered Muscle Stimulator Guidance, foreffectiveness in achieving repeated musclecontractions, powered muscle stimulatorstypically are capable of stimulating muscle forat least one second per burst, and are capableof providing at least one second of musclerelaxation between successive pulse bursts.Regarding the burst characteristics, our subjectdevice provides a muscle stimulation for 5seconds per burst and a muscle relaxation for 1second between successive pulse bursts.
		510(k) Premarket Notification
		SWIMS America Corp
		K230037
ON Time (seconds)	5 sec (6 sec period)	N.A	1-60 sec	Not identical.The subject device does not fall outside of therange of the secondary predicate device. Thisdifference does not raise new question ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
OFF Time (seconds)	1 sec (6 sec period)	N.A	1-60 sec	Not identical.The subject device does not fall outside of therange of the secondary predicate device. Thisdifference does not raise new question ofsafety and effectiveness compared to thesecondary predicate device.This characteristic does not apply to theprimary predicate device.
Treatment time(minutes)	Up to 60 minutes	N.A	Up to 60 minutes	Identical

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510(k) Premarket Notification

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Summary of Testing:

The technological characteristics of the BACK 3 System has of electrical safety, performance, biocompatibility, software and usability.

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.

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Conclusion:

Based on the comparison to the predicate devices and on the non-clinical performance testing results demonstrating that the BACK 3 is as and effective as the primary and secondary predicate devices, the BACK3 COLOR FDA cleared under 510(k) K214090, and the Evolve System with the T3 Applicator cleared under 510(k) K210877 and therefore may be legally marketed in the USA.

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.