Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.

Device Description

Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation. Slim UP® is used in environments such as Health Spa's and Beauty Salons. Slim UP® ULTRA has following major components: Main power switch, Control panel, Infrared unit, Distribution of electro-stimulation channels. Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case. Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect. Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.

AI/ML Overview

The acceptance criteria and study proving the device meets them are summarized below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics. Instead, it presents a comparison between the "Slim UP® ULTRA" and its predicate device, highlighting similarities and differences, and concludes that the differences do not raise new questions of safety or efficacy. The performance data provided focuses on compliance with general safety and biocompatibility standards rather than specific therapeutic endpoints.

Implicit Acceptance Criteria (based on predicate equivalence and safety testing):

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance and Justification
Functional Equivalence	Performance similar to predicate device for transcutaneous electrical muscle stimulation for improvement of buttock muscle tone.	The device operates on the basic principles of Electrostimulation, similar to the predicate. Despite differences in specific functional parameters (e.g., pulse duration, frequency, max output voltage/current, RMS current, number of programs), these differences are justified as not raising new questions of safety or efficacy due to compliance with relevant electromagnetic safety standards (IEC 60601-1, 60601-1-2, 60601-2-10). The inclusion of an IR unit is for patient comfort only, with no therapeutic effect, and is similar to a referenced device (Syneron Medical's Velashape K122579).
Biocompatibility	Patient-contacting parts (electrodes) must be biocompatible.	Patient-applied parts of Slim UP® ULTRA are biocompatible as per ISO 10993-1:2009. The electrodes used (FIAB PG474W, K091163) are 510(k) cleared.
Electrical Safety	Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.	Compliant with IEC 60601-1:2012, IEC 60601-1-2:2007, and IEC 60601-2-10:2000.
Software Verification	Software/firmware operates as intended and does not pose safety risks.	Software validation was completed to check safety requirements implemented by the firmware, ensuring it operates as indicated in the user manual and causes no risks.
Mechanical Safety	Housing materials and construction are safe and comply with relevant standards; physical characteristics do not raise new safety concerns.	Complies with EN ISO 14121-1:2007. The difference in physical dimensions and weight, as well as housing material (polycarbonate, nylon vs. ABS/asbestos for predicate), does not introduce additional safety issues, as patient body contact parts are biocompatible and the device complies with safety standards.

2. Sample Size for Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the context of evaluating the device's clinical performance or muscle tone improvement. The performance data provided pertains to engineering and safety testing. Therefore, there is no information on sample size or data provenance for a clinical test set.

3. Number of Experts and Qualifications for Ground Truth

The document does not describe a clinical study with a "ground truth" established by experts.

4. Adjudication Method

As no clinical study or ground truth establishment by experts is described, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the document. The device is a "Powered muscle stimulator," not an imaging or diagnostic AI device that would typically involve human readers for interpretation.

6. Standalone Performance (Algorithm Only)

The document does not describe a standalone performance study for an algorithm. The device, "Slim UP® ULTRA," is a physical medical device (powered muscle stimulator) with electrostimulation and an infrared unit, rather than a purely software-based AI diagnostic tool. Software validation was conducted to ensure the firmware operates as intended, but this is not a standalone algorithmic performance study in the typical sense for AI devices.

7. Type of Ground Truth Used

No ground truth, in the context of clinical endpoints or disease states, is described as being used for performance evaluation. The "ground truth" in the provided document relates to engineering and safety standards compliance.

8. Sample Size for the Training Set

The document does not describe an AI training set as it is not for an AI diagnostic device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no AI training set is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2016

Aime Medical, Inc % Mr. John O'Brien Regulatory Consultant AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, Florida 33572

Re: K151722

Trade/Device Name: Slim UP ULTRA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: February 18, 2016 Received: February 19, 2016

Dear Mr. O'Brien:

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151722

Device Name SLIM UP® ULTRA

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY (As required by 807.92)

I. SUBMITTER

Company Name: Aime Medical Inc. Address: 1258 West Bay Drive, Suite F. Largo, FL 33770 USA

Phone: +1-727-286-6227 Contact Person: Paul Guilbaud Email: paulg@AimeMedicalinc.com Date Prepared: 16 Feb 2016

REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572

Phone: 813-645-2855 x101 Fax: 813-645-2856

Contact Person: John O'Brien Email: jobrien@ajwtech.com

II. DEVICE

Name of Device: Common or Usual Name: Classification Name: Regulation Number: Device Panel: Regulatory Class: Main Product Code:

Slim UP® ULTRA Power muscle Stimulator. Power Muscle Stimulator 890.5850 Physical Medicine II NGX

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III. PREDICATE DEVICE

510(k) Number:	K123075
Product Code:	NGX
Manufacturer:	Well Life Healthcare Limited
Trade Name:	Buttock Muscle Stimulator Model WL 2413B; Buttock MuscleStimulator Model WL-2413E

The predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation.

Slim UP® is used in environments such as Health Spa's and Beauty Salons.

Slim UP® ULTRA has following major components:

Main power switch ■
. Control panel
Infrared unit
트 Distribution of electro-stimulation channels.

Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case.

Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect.

Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.

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The table below describes the list of associated accessories included with device.

Description	Quantity
Polycarbonate arc	1
100W IR lamp	7
Nylon screw+ washer for fixing the polycarbonate arc	5
Protective goggles	3
4 mm hexagonal wrench	1
Threaded pivot for fixing IR apparatus	2
Temperature probe	1
Disc for electrostimulation	100
510k cleared electrode with conductive gel under (K091163)	54

V. INDICATIONS FOR USE

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Subject and predicate devices are intended for similar treatment condition based on the principle of operation they uses

Parameter	Name of Device	Product Code	Regulation Number	510 K Number	Intended use	Predicate Device	Predicate Difference
Slim UP® ULTRA	Slim UP® ULTRA	NGX, NUV	878.4810, 890.5850	K151722	Slim UP® ULTRA is indicated for theuse by healthy persons to applytranscutaneous electrical musclestimulation (EMS) through skin contactelectrode for the purpose ofimprovement of muscle tone ofbuttocks muscles.	Buttock Muscle Stimulator(WL 2413 E Model)	-
						NGX	-
						890.5850	-
						K123075	-
						Buttock Muscle Stimulator, model WL-2413E, is -intended for use by healthypersons to apply transcutaneouselectrical muscle stimulation (EMS)through skin contact electrode for thepurpose of improvement of muscle toneof the buttocks muscles	Same

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Parameter	Slim UP® ULTRA	Predicate Device	PredicateDifference
Name of Device	Slim UP® ULTRA	Buttock Muscle Stimulator(WL 2413 E Model)
Product Component	1. Main power switch2. Control panel3. Infrared generation unit4. Electro-stimulation channels5. Skin contact electrodes	1. Electronic Stimulator Module2. Skin contact electrodes3. Conductive gel,4. 3AAA batteries,5. 2 read wires6. Storage bag	-
Treatment Energy	Electrostimulation	Electrostimulation	Same
Energy source	1) 16 Electrodes (K091163)2) 6 IR Lamps	K082065, Silicon pad electrodes (7.0 cm diameter)	Different
Pigmentation Effect	No	No	Similar
Dimensions	95 cm x 129 cm x 187 cm (WDH)	64 X20 X90 (WDH)	Different
Weight	161 Kg	0.08 Kg (80 Gm) (including batteries)	Different
Electrical Requirement	230VAC, Single-phase	1.5 V x 3 AAA size battery	Different
Safety features andcompliance with safetystandard	Compliant	Compliant	Same
Patient body contactmaterial	Biocompatible	Biocompatible	Same
Parameter	Slim UP® ULTRA	Predicate Device	Predicate Difference
Name of Device	Slim UP® ULTRA	Buttock Muscle Stimulator (WL 2413 E Model)	Different
Treatment Time	Between 15 and 60 minutes depend on treatment program selected	20-40 Minutes	Different
Compliance with Voluntary Standards?	Compliant	Compliant	Same
Housing Materials and Construction	Polycarbonate arcNylon screw and washer for fixing the polycarbonate arc	ABS	Different
Principle of Operation	Slim UP® ULTRA works on the basic principles of Electrostimulation. Skin contact electrodes are applied on treatment area.	The Buttock Muscle Stimulator, model WL-241 3E, comprises an electronic stimulator module with silicon pad electrodes which connect the signals from the stimulator to the skin. The electrodes are placed on skin	Same
Anatomical Site of Application	Buttocks	Buttocks	Same
Number of Electrode Used	16 Electrostimulation electrode	K082065, Silicon Pad Electrode (7.0 cm diameter)	Different
Mode OR Program name	2 TONE (F2 work phase)	WL-2413E	Different
Wave form	Biphasic	Biphasic	Same
Shape	Rectangular	Rectangular	Same

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AIME MEDICAL - SLIM UP ULTRA -AI RESPONSE

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Parameter	Slim UP® ULTRA	Slim UP® ULTRA	Predicate DeviceButtock Muscle Stimulator(WL 2413 E Model)	Predicate Difference
Maximum output voltage	100Vpp @ 500Ω184Vpp @ 1 KΩ234Vpp @ 2 KΩ240Vpp @ 10 KΩ(Single Phase)		40.8 V @500Ω70.0 V @2KΩ106.0 V @10KΩ	Different
Maximum output current	100mA @ 500Ω92 mA @ 1 KΩ58.5 mA @ 2 KΩ12 mA @ 10 KΩ(calculated on single positive pulse)		81.6mA@500 Ω35.0mAr@2KΩ10.6mA@10KΩ	Different
Duration of primary phase (µsec)	400 µsec		300 µsec	Different
Pulse duration	400 µsec		720 µsec	Different
Frequency (Hz)	40 Hz		70 Hz	Different
For multiphase	Symmetrical phasesYes		Yes	Same
Waveform Phase duration ms only		800 µsec	Not Applicable	Same
Method of Line current Isolation		Type BF	Type BF	Same
Number of output mode			04	Same
Pulse per burst		Same for each program	Same for each program	Same
Burst per second		Same for each program	Same for each program	Same

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Parameter	Slim UP® ULTRA	Predicate DeviceButtock Muscle Stimulator(WL 2413 E Model)	PredicateDifference
Name of Device	Slim UP® ULTRA
Burst duration	Same for each program	Same for each program	Same
Duty cycle	Same for each program	Same for each program	Same
Method of achievingzero net charge/pulse	Biphasic symmetric wave for eachpulse	Biphasic symmetric wave for eachpulse	Same
Regulated Current orRegulated Voltage?	Voltage	Voltage	Same
Software/Firmware/Microprocessor control?	Yes	Yes	Same
Automatic Shut Off?	Yes	Yes	Same
RMS (Root MeanSquare) Current	100mA during the active phase of thecurrent pulse, square wave with nullmedium value and period of 600μs	38.644mA (500Ω)16.907 mA (2KΩ)5.120 mA (10 Ω)	Different
Prescription or OTC	Prescription	OTC	Different
Number of TreatmentPrograms	7 different programs that should bechosen based on the individualrequirements of each case	N/A	Different
Method for ChannelIsolation	Sole transformer on all channels from12V and the tension that goes to theelectrostimulation channels (it is not aninsulating transformer).If current goes over 100mA (shortoutput transistor) a safety circuitintervenes by resetting the machine	Output coil	Different
Sterilization	Provided Non Sterile	Provided Non sterile	Same

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Comparison Feature	Slim UP Ultra	Predicate Device	Remarks
Net Charge	0 @ 500Ω (symmetrical positive and negative pulses)	0 (symmetrical stimulation biphasic wave)	Same
Max Phase Charge	40 μC @ 500Ω	24μc	Different
Max Average Current Density (jmax)	0.089 mA/cm² @ 500Ω	0.0997 mA/cm2	Different
Max Power Density (W/cm²)	0.00014 W/cm² @ 500Ω with electrodes 4x9 cm	0.00399 watts/cm2	Different
Burst Mode	Yes	Yes	Same

Significant output characteristics

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Similarities in Technological characteristics:

o Intended use
Product components ●
Treatment energy .
Pigmentation effect .
Safety feature and compliance with safety standard 0
Patient body contact material o
Compliance with voluntary standards o
Principle of operation o
Anatomical site of application o
o Waveform
Shape o
Symmetrical phases for multiphase waveform only ●
Method of line current isolation ●
Number of output mode ●
Pulse per Burst ●
Burst per Second ●
Bust duration ●
Duty cycle
Method for achieving zero net charge/pulse ●
Current/ Voltage regulation ●
Software/firmware control ●
Automatic shut off ●
Sterilization ●
Net Charge ●
Max Phase Charge ●
o Burst Mode

Differences in Technological characteristics

Energy Source ●
Physical characteristics (weight, dimensions) ●
Electrical Requirements ●
Treatment Time o
Housing material & construction ●
Number of Electrode ●
Mode or program name ●
Maximum output voltage ●
o Maximum output current
Duration of primary phase o

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Pulse duration ●
Frequency ●
Root Mean Square (RMS) Current ●
Prescription or OTC ●
Number of Treatment programs
0 Method for channel isolation
0 Maximum Phase Charge
O Max. current density
Max, power density

Justification of predicate differences:

Differernce-1: Energy Source - IR source

Predicate device: Buttock muscle stimulator does not contain IR modality.

New Device: The Slim UP® ULTRA contains IR modality in addition to Electrostimulation modality.

Intended Use: Same

Different questions of Safety and effectiveness? No

Justification of Difference:

IR source does not have any therapeutic effect it is just used for patient comfort only. Also IR modality used in subject device is not able to raise and maintain body temperature above 38-41 degree Celsius for 10 minutes. IR source used in Slim UP® ULTRA is similar to reference device i.e. Syneron Medical's Velashape (K122579). So this minor technological difference does not raise any new questions of safety and efficacy.

Difference-2: Physical Characteristics (Dimension and weight)

Predicate device: Buttock muscle stimulator is 0.08 Kg in weight and has physical dimensions of 64cm Width X20cm Diameter X90 cm Height.

New Device: The Slim UP® ULTRA has physical dimension of 95cm Width X 129cm Diameter X 187cm Height and 161 Kg in weight.

Intended Use: Same

Different questions of Safety and effectiveness? No

Justification of Difference:

The difference in physical dimensions and weight doesn't introduce any additional safety issues. Due to its compact size Slim UP® ULTRA can be located in any booth, can be adapted to any bed and can be moved anywhere.

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Difference-3: Housing material and construction

Predicate device:

Buttock muscle stimulator has asbestos as primary housing material.

New Device:

Different parts of Slim UP® ULTRA were made from different housing material. It has polycarbonate arc, nylon screw and washer for fixing the polycarbonate arc.

Intended Use: Same

Different questions of Safety and effectiveness? No Justification of difference:

This predicate difference will not raise any questions of safety and efficacy as patient body contact parts of Slim UP® ULTRA are biocompatible and Slim UP® ULTRA complies with international safety standard EN ISO 14121-1:2007- Safety of the equipment. Risk evaluation part-1: Principles.

Difference-4: Number of electrodes

Predicate device: The information regarding number of electrodes in predicate device is not available.

New device: Slim UP® ULTRA has 16 skin contact electrodes.

Intended Use: Same

Different questions of Safety and effectiveness? No

Justification of difference:

The difference in number of electrodes do not raise new question of safety or effectiveness. Slim UP® ULTRA use 510k cleared electrode FIAB PG474W (K091163). Apart from this electromagnetic safety of subject device has been established by conducting EMC testing in complies with international EMC standard 60601-1-2 and 60601-2-10. So this difference will not raise any additional questions of safety and efficacy.

Difference-5: Functional parameters like Mode or Program name, Pulse duration, Number of output mode, pulse per burst, burst per second, Burst duration, Duty cycle, RMS current, Number of treatment program Method of channel isolation, Maximum current and power density.

Predicate device:

Buttock muscle stimulator has following different functional parameters: Mode or Program name: WL-2413E Pulse Duration: 720 usec Number of output mode: 04 Pulse per burst: Same for each program Burst per second: Same for each program

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Burst duration: Same for each program Duty cycle: Same for each program RMS current: 38.644mA (500Ω), 16.907mA (2KΩ), 5.120 mA (10 Ώ) Number of treatment program: N/A Method of Channel isolation: Output coil Maximum Current density: 0.0997 mA/cm2 Maximum Power density: 0.00399 watts/cm2

New Device:

Slim UP® ULTRA has following different functional parameters:

Mode or Program name: 2 TONE (F2 work phase)

Pulse Duration: 400 usec

Number of output mode: N/A

Pulse per burst: 160

Burst per second: 1/8

Burst duration: 4 Sec

Duty cycle: 1/2

RMS current: 100mA during the active phase of the current pulse, square wave with null medium value and period of 600us

Number of treatment program: 7 different programs that should be chosen based on the individual requirements of each case.

Method of channel isolation: Sole transformer on all channels from 12V and the tension that goes to the electrostimulation channels (it is not an insulating transformer). If current goes over 100mA (short output transistor) a safety circuit intervenes by resetting the machine

Maximum current density: 2, 8 mA/cm2 @ 500Ω

Maximum power density: 8, 96 mW/cm² @ 500Ω with electrodes 4x9 cm

Intended Use: Same

Different questions of safety and effectiveness: No Justification of difference:

The minor difference in functional parameter between predicate device and subject device do not raise new questions of safety or efficacy as Electromagnetic safety of Slim UP® ULTRA has been established by conducting EMC testing in complies with international EMC standard 60601-1. 60601-1-2 and 60601-2-10.

Difference-6: Electrical Requirement

Predicate device:

Runs on 3 AAA batteries at 1.5v. New Device: 230VAC, Single-Phase Intended Use: Same Different questions of Safety and effectiveness? No Justification of difference:

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The difference in Electrical Requirements between predicate device and subject device do not raise new questions of safety or efficacy as Electromagnetic safety of Slim UP® ULTRA has been established by conducting EMC testing in complies with international EMC standard 60601-1, 60601-1-2 and 60601-2-10.

The conclusion of this technical comparison is that Slim UP® ULTRA is substantially equivalent to the Buttock Muscle Stimulator and have been verified by subsequent testing. Any difference between Predicate device and Slim UP® ULTRA do not raise any new questions for safety and efficacy.

PERFORMANCE DATA

The following performance testing was provided in support of the substantial equivalence determination.

Biocompatibility Testing

Patient applied parts of Slim UP® ULTRA are biocompatible as per the International standard ISO 10993-1:2009- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Electrical safety and electromagnetic compatibility (EMC)

The following standards have been complied within designing, manufacturing and testing of Slim UP® ULTRA:

IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety.
IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General ● Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-2-10:2000: Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
EN ISO 14121-1:2007- Safety of machinery -- Risk assessment -- Part 1: Principles. o

Software Verification and Validation Testing

Software validation was completed to check the safety requirements implemented by the firmware resident on the Microcontroller used on the Slim Up® Ultra, in order to provide objective evidence that the firmware itself operates as indicated in the user manual and does not cause any risks connected to its use.

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CONCLUSION I.

The performance data demonstrates that the Slim UP® ULTRA performs as intended and similar to that of predicate devices and exhibits comparable mechanical, functional and technological characteristics to that of the predicate device.

Any technological or engineering differences existing between subject device and predicate devices is insignificant in terms with safety and effectiveness of subject device.

Based on these factors, the Slim UP® ULTRA can be considered substantially equivalent to the predicate device and safe and effective for its intended use.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).