October 25, 2018Bio-Medical Research LtdEoin KeatingQuality EngineerParkmore Business Park WestGalway, H91 NHT7 IrelandRe: K180688Trade/Device Name: SLENDERTONE CoreFit Abs 8, Type 734Regulation Number: 21 CFR 890.5850Regulation Name: Powered Muscle StimulatorRegulatory Class: Class IIProduct Code: NGXDated: September 12, 2018Received: September 24, 2018Dear Eoin Keating:We have reviewed your Section 510(k) premarket notification of intent to market the device referencedabove and have determined the device is substantially equivalent (for the indications for use stated in theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. Although this letter refers to your product as a device, please be aware thatsome cleared products may instead be combination products. The 510(k) Premarket Notification Databaselocated at /cfpmn/pmn.cfm identifies combinationproduct submissions. The general controls provisions of the Act include requirements for annual registration,listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. Weremind 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 besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcementsconcerning your device in the Federal Register.U.S. Food & Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993www.fda.govDoc ID# 04017.03.01

K180688 - Eoin KeatingPage 2Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDAhas made a determination that your device complies with other requirements of the Act or any Federalstatutes and regulations administered by other Federal agencies. You must comply with all the Act'srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) fordevices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products ceRegulatoryInformation/ucm597488.htm); goodmanufacturing 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, ifapplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 10001050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part803), please go to oblem/default.htm.For comprehensive regulatory information about medical devices and radiation-emitting products, includinginformation about labeling regulations, please see Device gulationandGuidance/) and CDRH Learn( Additionally, you may contact the Division of Industry andConsumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website( for more information or contact DICE by email ([email protected]) or phone(1-800-638-2041 or 301-796-7100).Sincerely,Vivek J. Pinto -Sfor Carlos L. Peña, PhD, MSDirectorDivision of Neurologicaland Physical Medicine DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationForm Approved: OMB No. 0910-0120Expiration Date: 06/30/2020Indications for UseSee PRA Statement below.510(k) Number (if known)K180688Device NameSLENDERTONE CoreFit Abs 8, Type 734Indications for Use (Describe)The SLENDERTONE CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, forstrengthening of abdominal muscles, and for the development of a firmer abdomen.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.This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]“An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number.”FORM FDA 3881 (7/17)Page 1 of 1PSC Publishing Services (301) 443-6740EF

Bio-Medical Research Limited,Parkmore Business Park West, Galway, Ireland.Tel: 353 (0)91 774300 Fax: 353 (0)91 774301This 510(k) summary of safety and effectiveness is being submitted in accordance with therequirements of 21 CFR 807.92.I. SUBMITTERName:Mike KilkellyAddress:Bio-Medical Research Ltd.,Parkmore Business Park West,Galway, IRELANDTelephone: 353 91 774395Fax: 353 91 774301 or 353 91 774302E-Mail:[email protected]:September 21, 2018II. DEVICETrade Name of Device:SLENDERTONE CoreFit Abs 8, Type 734Common Name:Powered muscle stimulatorRegulation Number:21 CFR 890.5850Regulation Description:Stimulator, muscle, powered, for muscle conditioningProduct Code:NGXDevice Class:2III. PREDICATE DEVICES510(k) Number:K100320 (Primary Predicate)Manufacturer:Bio-Medical Research Ltd.Trade Name:Slendertone System Ultra, Type 390, Model E70/X70Page 1 of 9

IV. DEVICE DESCRIPTIONThe SLENDERTONE CoreFit Abs 8, Type 734 is a portable neuromuscular electricalstimulator intended to deliver electrical stimulation to the abdominal muscles. The deviceincludes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable andinstructions for use. It contains ten pre-installed programs.The control unit is connected to the abdominal belt garment via three magnetic connectors.The control unit contains the primary controls for operation of the device and push buttons areavailable for switching the unit on or off and to increase or decrease the stimulation intensity.The SLENDERTONE CoreFit Abs 8, Type 734 contains an Organic Light-Emitting Diode(OLED) display which indicates status relating to battery charge and stimulation. Power isderived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by usingthe supplied USB cable.The SLENDERTONE CoreFit Abs 8, Type 734 is rated as IP22 for ingress protection. Theuser has no access to the wiring or connectors within the garment. For purposes of hygiene,the garment may be cleaned and instructions for garment care are included in the user manual.V. INDICATIONS FOR USEThe SLENDERTONE CoreFit Abs 8, Type 734 is indicated for the improvement ofabdominal muscle tone, for strengthening of abdominal muscles, and for the development of afirmer abdomen. SLENDERTONE CoreFit Abs 8, Type 734 is intended for over-the-counteruse.The Indications for Use statement for the SLENDERTONE CoreFit Abs 8, Type 734 isidentical to the predicate devicePage 2 of 9

VI. BIOCOMPATIBILITY EVALUATIONThe SLENDERTONE CoreFit Abs 8, Type 734 uses the same adhesive gel pads(electrodes) as the predicate device Slendertone System Ultra.Biocompatibility testing of the SLENDERTONE CoreFit Abs 8, Type 734 garmentassembly was carried out. The four test studies conducted were as follows;1. Cytotoxicity Test: MTT Method MEM with 10% FBS Extract2. Cytotoxicity Test: MTT Method MEM Extract3. Skin sensitization: Buehler test in guinea pigs4. Skin irritation Test: Direct contact.A summary of the four biocompatibility tests carried out can be seen in the below table.TestResultToxicological ConclusionCytotoxicity Test: MTTMethod MEM with 10%FBS ExtractPotential toxicity at extractconcentration 75%No toxicological risk to users.Cytotoxicity Test: MTTMethod MEM ExtractNo potential cytotoxic potentialNo toxicological risk to users.Skin sensitization:Buehler test in guineapigsDermal scoring using theMagnusson and Kligman scoringsystem was graded as 0 (novisible change)No toxicological risk to users.Skin irritation Test: DirectcontactNo abnormal signs were observedduring the study. The response ofskin on test side did not exceedthat on the control side.No toxicological risk to users.VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THEPREDICATE DEVICEThe following table summarizes the similarities and differences between the technologicalcharacteristics of the new device and primary predicate device Slendertone System Ultra.Page 3 of 9

Bio-Medical Research Limited,Parkmore Business Park West, Galway, Ireland.Tel: 353 (0)91 774300 Fax: 353 (0)91 774301Table IBasic Unit Characteristics1. 510(k) Number2. Device Name, Model3. Manufacturer (Contract)4. Power Source- Method of line Isolation- Patient Leakage Current5. No. of Output Modes6. Number of Output Channels- Synchronous/Alternating?- Method of channel isolation7. Regulated Current or Regulated Voltage8. Software/Firmware/Microprocessor Control?9. Automatic overload Trip?10. Automatic No-Load Trip?11. Automatic Shut Off12. Patient Override Control?13. Indicator Display- On/Off Status?New DevicePredicate DeviceSlendertone System Ultra,Type 390, Model E70/X70(To be Assigned)K100320SLENDERTONE CoreFit Abs 8,Slendertone System UltraType 734Type 390, E70/X70ChinaTurnkeySolutionsLogistics ChinaTurnkeySolutionsLogistics(Shenzhen) Co.,(Shenzhen) Co.,Futian Free Trade ZoneFutian Free Trade ZoneCHINA 518038CHINA 5180383.7V Lithium Polymer Single Cell 3.6V NiMh Battery PackRechargeableRechargeableNo line connection possible when connected No line connection possible when connectedto bodyto bodyNot applicable, no line connection, no AC Not applicable, no line connection, no ACcharger connection or operation. Connection charger connection or operation. Connectionmethod does not allow AC charger method does not allow AC chargerconnection to Patient.connection to Patient.1 (Symmetric, Pulsed, Biphasic)1 (Symmetric, Pulsed, torConstant CurrentConstant CurrentYesYesYesYesSLENDERTONE CoreFit Abs 8,Type 734YesYesYes, pauseimmediately.YesbuttonYes, OLED DisplaystopsYestreatment Yes, pauseimmediately.buttonstopstreatmentYes, LCDPage 4 of 9

Table IBasic Unit CharacteristicsNew Device- Low Battery?- Voltage/Current Level?14. Timer range (minutes)15. Compliance with Voluntary Standards?Yes, OLED DisplayYes, OLED Display20-40 minutesIEC 60601-1: 2005 & A1:2012IEC 60601-2-10:2012EN 60601-1-2: 2007IEC 60601-1-11:2010IEC 60601-1-6:2010IEC 62133:2012FCC (47 CFR Part 15, Subpart B)Predicate DeviceSlendertone System Ultra,Type 390, Model E70/X70Yes, LCDYes, LCD20-40 minutesIEC 60601-1:1988 & A1:1991, A2:1995IEC 60601-2-10:1987 & A1 2001IEC 60601-1-2:2001 (EN 60601-1-2:2001)CISPR 22:2003/CFR 47 Part 15:2005IEC 60601-1-6:2004 (EN 60601-1-6:2001)Battery Charger: IEC 60950 and UL 1950FCC Rules Subpart B16. Compliance with CFR 21 898?17. Weight (unit)Yes37g (incl. batteries)Yes116g (inc. batteries)18. Dimensions (un.){W x H x D}19. Housing Materials and Construction57 x 57 x 15 mm approx.60 x 23 x 115mm approx.SLENDERTONE CoreFit Abs 8,Type 734Injection moulded thermosetting plastic,Injection moulded thermosetting plasticwith a thermoplastic elastomer (TPE) keypadPage 5 of 9

Table IIOutput CharacteristicsWaveformShapePulsed, Symmetrical, BiphasicRectangular, with interphase intervalPredicate DeviceSlendertone System Ultra,Type 390, Model E70/X70Pulsed, Symmetrical, BiphasicRectangular, with interphase intervalMaximum Output Voltage (RMSV) ( /10%)7.58V @ 500Ω14.4V @ 2kΩ@ 10kΩ: no output for 10kΩ [email protected][email protected][email protected]ΩPulse Width15.16mA @ 500Ω7.2mA @ 2kΩ@ 10kΩ: no output for 10kΩ resistance730 µ[email protected][email protected]Ω620µ[email protected]Ω730 µsBaseline to peak current @500Ω72mA70mAFrequency (Hz)50-70 Hz50-70 HzFor interferential modes:- Beat FrequencyN/AN/AFor multiphasic waveforms only:- Symmetrical phasesYesYes- Phase Duration200 - 315µs200/225/250/275/300/315 µsNet Charge (µC per pulse)[email protected]ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse1 phase 22.8 µC @500Ω2 phase 45.6 µC @500Ω0.216 mA/cm2 @500Ω[email protected]ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse1 phase 22 µC @500Ω2 phase 44 µC @500Ω0.21 mA/cm2 @500ΩVp 2 x2 xPW1freqMaximum Output Current (RMSA) ( /10%)Maximum Phase Charge (µC)C Ip*PWMaximum Current Density (mA/cm2)New DeviceSLENDERTONE CoreFit Abs 8,Type 734Page 6 of 9

Table IIOutput CharacteristicsNew DeviceSLENDERTONE CoreFit Abs 8,Type 734Predicate DeviceSlendertone System Ultra,Type 390, Model E70/X70Maximum Power Density (W/ cm2)Using smallest electrode conductivesurface