JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.

JetBoots PRO Plus is two leg shaped garments, one that acts a Lead and the other a Support boot. Each boot is comprised of a console (pressure control unit), a control panel or support power button, and a compression garment in the shape of a boot. The console contains an air pump (compressor) to generate the air pressure, four valves to control the outlet air, a circuit board with embedded firmware to control the pressure, an internal rechargeable battery, and a charging port. The console is fixed to the bottom of the foot on each compression garment, which allows for easy wearing on and off.

Each compression boot has four internal overlapping chambers that can be inflated independently of each other. The device can provide different compression levels in the range from 20mmHg to 100mmHg depending on the user's selection. Hold time is set within the range of 0-10 seconds depending on the preset selected and release time is set by default to 15 seconds.

The lead and support JetBoots PRO Plus boots are each powered by an internal rechargeable battery or by an external DC Power Adapter, plugged into a wall electrical outler. The batteries are located inside each console and can be charged while the device operates. A 72W medical grade DC power adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 15.0V, 4.8A. The 72W DC power adapter is able to support both boots to work, charge, and work and charge at the same time if using the splitter cable provided.

The JetBoots PRO Plus are also capable of providing therapeutic warming via the included Light Emitting Diode (LED) Strips. The LEDs emit an infrared light frequency at 850nm and are provided as an optional treatment modality. They can be utilized for a maximum of 45 minutes, either as a standalone therapy or in tandem with the JetBoots PRO Plus' primary device function, pneumatic compression. Therapeutic warming via infrared LEDs is considered to be an "Other Device Function."

The JetBoots PRO Plus also capable of providing therapeutic vibrations via included vibrating pill motors. These are included for an improved user experience and are considered to be an "Other Device Function" that has no impact on the JetBoots PRO Plus' primary device function.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a medical device called "JetBoots PRO Plus." However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to AI/algorithm performance, as the device is a powered inflatable tube massager with additional functions like infrared LED heat and therapeutic vibrations, not an AI-powered diagnostic or assistive device.

Therefore, I cannot provide the information requested in the prompt based on the given text.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

Indications for Use: (Page 3-4, 5)
Technological Characteristics: (Pages 6-8, Table 1, "Comparison in Detail(s)")
Performance Comparison: (Pages 9-12, Table 2)
Safety Comparison: (Page 13, Table 3)
Performance Data (Bench/Non-Clinical Testing): Electrical safety, EMC, biocompatibility, software V&V, temperature range testing, mechanical testing (Page 13-14).

There is no mention of an algorithm or AI in the context of device performance or clinical studies. The "Software Verification and Validation Testing" section (Page 14) refers to general software lifecycle processes (IEC 62304) for embedded firmware controlling the pressure, not for an AI/ML component.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 30, 2024

Therabody, Inc. % Gina Walljasper Principal Consultant GPW Enterprises, LLC 47 Gatehouse Rd Bedminster, New Jersey 07921

Re: K241256

Trade/Device Name: JetBoots PRO Plus Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILY, IRO Dated: August 7, 2024 Received: August 7, 2024

Dear Gina Walljasper:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)
------------------------------

K241256

Device Name

JetBoots PRO Plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X 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.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary (as required by 807.92)

(1) SUBMITTER AND OWNER/OPERATOR:

THERABODY, Inc 1640 S Sepulveda Blvd., Suite 300 Los Angeles, CA 90025 Registration Number: 3012386142 FEI Number: 3012386142 Contact Person: CI Frederick III, Director, Quality & Regulatory Compliance Telephone: (484) 888-1290 Email: cj.frederick@therabodycorp.com Date prepared: May 9, 2024

Application Correspondent:

Contact Person: Gina Walljasper Company: GPW Enterprises, LLC Address: 47 Gatehouse Rd., Bedminster, NJ 07921 Tel: (908) 507-6503 Email: gina.gpwconsulting@gmail.com

(2) DEVICE NAME:

Trade Name: JetBoots PRO Plus Common Name: Powered inflatable tube massager Classification Name: Powered inflatable tube massager Device Classification: Class II Review Panel: Neuromodulation and Physical Medicine Devices (DHT5B) Regulation Number: 21 CFR 890.5650 Product Code: IRP, ILY, IRO

(3) PREDICATE & REFERENCE DEVICE(S): Substantial equivalence is based on following legally marketed devices.

Sponsor	Therabody, Inc. (formerly Theragun, Inc.)
Device Name and Model	RecoveryAir PRO
510(k) Number	K211745
Product Code	IRP
Regulation Number	21 CFR 890.5650
Regulation Class	II

Primary Predicate Device

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Primary Reference Device

Sponsor	LTBIO Co., Ltd.
Device Name and Model	OLIZ LTB-1000A
510(k) Number	K221189
Product Code	ILY
Regulation Number	21 CFR 890.5500
Regulation Class	II

Secondary Reference Device

Sponsor	Pain Relief Technologies
Device Name and Model	ElectroPulse – Pain Relief
510(k) Number	K062532
Product Code	NUH, ILY, IRO
Regulation Number	21 CFR 882.5890
Regulation Class	II

(4) DESCRIPTION OF THE DEVICE:

JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.

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(5) INDICATIONS FOR USE:

JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.

(6) COMPARISON WITH PREDICATE & REFERENCE DEVICES:

The following table is a comparison of Therabody's JetBoots PRO Plus, Predicate and Reference devices.

Therabody's JetBoots PRO Plus is substantially equivalent in terms of the technological characteristics, features, specifications, materials, primary mode of operation and indications for use, to the RecoveryAir PRO, K211745. Comparisons to the Primary Reference Device quoted below, OLIZ LTB-1000A, K221189, as well as the Secondary Reference Device, ElectroPulse – Pain Relief, K062532, demonstrate that the additional modalities of Infrared LED Heat and Therapeutic Vibration do not raise additional concerns of safety and effectiveness. Any differences between the Subject Device, PrimaryPredicate Device, and Reference Devices do not raise new issues of safety or effectiveness.

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Comparison in Detail(s):

Table 1 General Comparison

Item	Proposed DeviceK241256	Primary PredicateDevice K211745	Primary ReferenceDevice K221189	Secondary ReferenceDevice K062532	Remark
Manufacturer	Therabody, Inc.	Therabody, Inc.(FormerlyTheragun, Inc.)	LTBIO Co., Ltd.	Pain ReliefTechnologies
Product Name	JetBoots PRO Plus	RecoveryAir PRO	OLIZ LTB-1000A	ElectroPulse - PainRelief
ClassificationName	Powered inflatabletube massager	Powered inflatabletube massager	Infrared Lamp	TranscutaneousElectrical Stimulatorfor Pain Relief
Product Code	IRP, ILY, IRO	IRP	ILY	NUH, ILY, IRO	Similar
Regulation No.	21CFR 890.5650	21CFR 890.5650	21CFR 890.5500	21CFR 882.5890	Similar
Class	2	2	2 (Exempt, Underwent510k)	2	SAME
Indication forUse	JetBoots PRO Plus isan air compressiontherapy deviceintended to providegraduated pressure tothe legs.JetBoots PRO Plus isindicated for thetemporary relief ofminor muscle achesand pains, and for atemporary increase inblood circulation tothe legs in peoplewho are in goodhealth.JetBoots PRO Plussimulates kneadingand stroking oftissues by using aninflatable garment.	The RecoveryAirPRO is an aircompression therapydevice intended toprovide graduatedpressure tocompressiongarments.The RecoveryAirPRO is indicated forthe temporary reliefof minor muscleaches and pains, andfor a temporaryincrease in bloodcirculation to thetreated areas inpeople who are ingood health.The RecoveryAirPRO simulateskneading andstroking of tissuesby using aninflatable garment.	The OLIZ LTB-1000A is intended todeliver heat in the IRspectrum to providetopical heating for thepurpose of elevatingtissue temperature; forthe temporary relief ofminor muscle and jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation of muscletissue; and totemporarily increaselocal blood circulation.	TENS: Used for thetemporary relief ofpain associated withsore and itchingmuscles in the lowerback due to strainfrom exercise, ornormal household andwork activities.Vibration: RelaxingMuscles and relievingminor aches andpains.Heat Lamp: Emitsenergy at neat infraredfrequencies to providetopical heating and toprovide temporaryrelief of minor muscleand joint pain,arthritis and musclespasm; relievingstiffness, promotingrelaxing of muscletissue, and totemporarily increaselocal bloodcirculation.	SAME
Prescription/OTC	OTC	OTC	OTC	OTC	SAME
Item	Proposed Device	Primary PredicateDeviceK211745	Primary ReferenceDevice K221189	SecondaryReference DeviceK062532	Remark
Power Source	Power Adapter:AC Input: 100 –240V AC, 50/60Hz,DC Output: 15.0V,4.8A, 72WOrInternal Battery	Power Adapter:AC Input: 100 –240V AC, 50/60Hz, 12V or internalbattery	Li-ion batteries(3.7v_1800mA x2)	Not provided.	Similar
Dimensions(LWH)	Console &Compression boot(Lead or Support,deflated and fullyextended):• S-size:36.8in (L) 5.3in (W) 14.8 (H)• M-size:42.9in (L) 5.3in (W) 16.1 (H)• L-size:46.5in (L) 5.3in (W) 16.1 (H)	8.6in (L) 6.7in (W)5.1in (H)	Not provided.	Not provided.	Similar
Weight	S-size: 6.0lb (perboot)M-size: 6.4lb (perboot)L-size: 6.7lb (perboot)	4.202 pounds	Not provided.	Not provided.	Similar
HousingMaterials	Molded PC+ABSEnclosure	Molded ABSEnclosure	Not provided.	Not provided.	Similar
Sleeves	Compression bootssleeves attached toconsoles. Sleeves(extended) only:S: 80cm (L)* 37.5cm (H)M: 95cm (L)* 41.0cm (H)L: 1050cm (L)* 41.0cm (H)	RecoveryAirCompression Boots95*28.7cm	Not provided.	Not provided.	Similar
Number ofChambers	4	4	Not provided.	Not provided.	SAME
Item	Proposed Device	Primary PredicateDeviceK211745	Primary ReferenceDevice K221189	SecondaryReference DeviceK062532	Remark
Modes	Sequential, ISO, orStatic Flow Cycles	Sequential, ISO orRehab (wave) FlowCycles	Not Provided	Not provided.	Similar
	Sequential mode thatapplies a directionalmassage, starting atthe base of thetreated area, andprogresses upwardstowards the torso andthen releases.Image: Sequential cycle mode	Sequential modethat applies adirectional massage,starting at the baseof the treated area,and progressesupwards towardsthe torso and thenreleases.Image: Sequential cycle mode
	ISO mode thatapplies a directionalmassage to a smaller,user- selected area.The first chamberinflates, and after afew seconds, thesecond chamberstarts to inflate untilboth chambers reachthe set pressure. Thenboth chambersdeflate, and after apause the processstarts again.Image: ISO cycle mode	ISO mode thatapplies a directionalmassage to asmaller, user-selected area. Thefirst chamberinflates, and after afew seconds, thesecond chamberstarts to inflate untilboth chambersreach the setpressure. Then bothchambers deflate,and after a pause theprocess starts again.Image: ISO cycle mode
	Flow cycles Progress1: first inflateChamber 1 to targetpressure, then hold &release. then go toProgress 2. Progress2: first inflatedChamber 1 to target	Wave mode: Thefirst chamberinflates and after a
Item	Proposed Device	Primary PredicateDeviceK211745	Primary ReferenceDevice K221189	SecondaryReference DeviceK062532	Remark
	pressure, then inflateChamber 2 and holdChamber 1. whenChamber 2 reach thetarget pressure, holdchamber 1 & 2 forspecified time, thenrelease totally, thengo to Progress 3Progress 3: firstinflated Chamber 1 totarget pressure, theninflate Chamber 2and hold Chamber 1.when Chamber 2reach the targetpressure, holdchamber 1 & 2, &start to inflateChamber 3, whenChamber 3 reach tothe target pressure,then hold chamber 1,2, 3 for specifiedtime then releasetotally. then go toProgress 4.	few seconds, the 1stand 2nd chamberstarts to inflate untilboth chambersreach the setpressure. Then thedeflation on 1stchamber, the 2ndand 3rd chambersstarts to inflate untilthe both chambersreach the setpressure; thendeflate the 2ndchambers inflate 3rdand 4th chambersuntil the bothchambers reach theset pressure.Image: Wave cycle mode
	Progress 4: firstinflated Chamber 1 totarget pressure, theninflate Chamber 2and hold Chamber 1.when Chamber 2reach the targetpressure, holdchamber 1 & 2, &start to inflateChamber 3, whenChamber 3 reach tothe target pressure,then hold chamber 1,2, 3,& start to inflateChamber 4, whenChamber 4 reach tothe target pressure,then hold chamber 1,2, 3 &4 for specifiedtime then releasetotally. then go backto Progress 1 again.	Flow cyclesProgress 1: firstinflate Chamber 1to target pressure,then hold & release.then go to Progress2. Progress 2: firstinflated Chamber 1to target pressure,then inflateChamber 2 and holdChamber 1. whenChamber 2 reachthe target pressure,hold chamber 1 & 2for specified time,then release totally,then go to Progress3 Progress 3: firstinflated Chamber 1to target pressure,then inflateChamber 2 and holdChamber 1. whenChamber 2 reachthe target pressure,
Item	Proposed Device	Primary PredicateDeviceK211745	Primary ReferenceDevice K221189	SecondaryReference DeviceK062532	Remark
	Image: Chamber 1, Chamber 2, Chamber 3Image: [Illustration of chambers inflating]Static CycleThe chambers inflateone at the timestarting at chamber 1while maintainingnegative gradient ofcompression alongthe leg. The pressureis limited to 20mmHg to 30 mmHg.Once inflated, thechambers do notdeflate during thetreatment. While thegarment is inflated, itcomes incontact with the legsto optimize thetreatment of vibrationand infrared LEDlight by ensuringoptimal contact withthe leg.Image: Static Cycle	hold chamber 1 &2, & start to inflateChamber 3, whenChamber 3 reach tothe target pressure,then hold chamber1, 2, 3 for specifiedtime then releasetotally. then go toProgress 4.Progress 4: firstinflated Chamber 1to target pressure,then inflateChamber 2 and holdChamber 1. whenChamber 2 reachthe target pressure,hold chamber 1 &2, & start to inflateChamber 3, whenChamber 3 reach tothe target pressure,then hold chamber1, 2, 3,& start toinflate Chamber 4,when Chamber 4reach to the targetpressure, then holdchamber 1, 2, 3 &4for specified timethen release totally.then go back toProgress 1 again.Image: Chamber 1, Chamber 2, Chamber 3Image: [Illustration of chambers inflating]
Device PressureRange	20 - 100 mmHg,steps of 5mm Hg	20 – 100 mmHg	Not provided/Notapplicable	Not provided/notapplicable	SAME
MaximumDevice SurfaceTemperature	43.2° C	Not provided/Notapplicable	Less than 40° C	Not provided.	Similar
HighestMeasured SkinTemperatureDuringTreatment	36.8° C	Not provided/Notapplicable	Not provided	Not provided.	Similar
Item	Proposed Device	Primary PredicateDeviceK211745	Primary ReferenceDevice K221189	SecondaryReference DeviceK062532	Remark
Wavelengths	655nm, 850nm	Not provided/Notapplicable	655nm, 855nm	Not provided.	SAME
Treatment Time	10min - 60min, stepsof 5min forPneumaticCompression10min - 45min forInfrared LED	10min - 90min, stepof 5min	15 minutes, twice perday. Total of 210minutes per week.	Not provided.	Similar
Hold time withincycle	0 – 10 secondsdepending on theselected preset.	2 - 10 seconds	Not Provided/NotApplicable	Not Provided/NotApplicable	Similar
Pause intervalbetween cycles	15 seconds	10 - 70 seconds	Not Provided/NotApplicable	Not Provided/NotApplicable	Similar
MobileApplication	Device does notconnect to a MobileApplication.	BluetoothCommunication	Not Provided	Not Provided	Similar
Patient Contact	Non-conductiveappliances	Non-conductiveappliances	Not Provided	Not Provided	SAME
GarmentMaterial	Polyether NylonFabric	Polyether NylonFabric	Not Provided	Not Provided	SAME
Software/Firmware/MicroprocessorControl	Microprocessor	Microprocessor	Not Provided	Not Provided	SAME
Device Function	Compressor andvalve system whichsequentially inflatescells of appliance,Light EmittingDiodes	Compressor andvalve system whichsequentially inflatescells of appliance	Light Emitting Diodes	Not Provided	SAME

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510(K) PREMARKET NOTIFICATION FOR THERABODY, INC. JetBoots PRO Plus ______________________________________________________________________________________________________________________________________________________________________________

Table 2 Performance Comparison

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Table 3 Safety Comparison

Item	Proposed Device	Primary Predicate DeviceK211745	Primary Reference Device K221189	Secondary Reference Device K062532	Remark
Electrical Safety	Complies with IEC 60601-1,IEC 60601-1-11	Complies with IEC 60601-1,IEC 60601-1-11	Complies with IEC 60601-1, IEC 60601-1-11	Not Provided.	SAME
Photobiological Safety	Complies with IEC 62471Complies with IEC 60601-2-57	Does not contain components that required testing to demonstrate Photobiological Safety.	Not Provided	Not Provided.	SAME
EMC	Complies with IEC 60601-1-2ANSI C63.18-2014	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2	Not Provided.	Similar

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Biocompatibility	Complies with ISO10993-5 and ISO	Complies with ISO10993-5 and ISO	Complies with ISO10993-1 and ISO	Not Provided.	SAME
	10993-10ISO 10993-23	10993-10ISO 10993-23	10993-5ISO 10993-10
Label andLabeling	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatoryRequirements	Not Provided.	Not Provided.	SAME

(7) PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination, Electrical safety and electromagnetic compatibility (EMC) JetBoots PRO Plus passed all electrical safety and EMC tests, Electrical Safety Testing was conducted in accordance with:

IEC 60601-1:2005, AMD1:2012 + AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010 + A1:2013 + A2:2020, Medical devices – Application of usability engineering to medical devices
. IEC 60601-1-11:2015, Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60601-2-83:2019, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
o IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems
the Advancement of Medical Instrumentation for the evaluation of Wireless Coexistence

EMC Testing was conducted in accordance with:

IEC / EN 60601-1-2:2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and Tests
o ANSI C63.18-2014

Sterilization & Shelf-life Testing: JetBoots PRO Plus is not sold sterile or ever intended to be sterilized. Therefore, sterilization testing was not necessary to demonstrate the safety or performance of the device. The subject device has a shelf-life of 1000 hours.

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Biocompatibility Testing:

Cytotoxicity, Irritation and Sensitization testing was conducted to demonstrate the biocompatibility of patient-contacting materials of JetBoots PRO Plus in accordance with:

ISO 10993-5:2009, biological evaluation of medical devices part 5: tests for in vitro ● cytotoxicity
ISO 10993-10:2021, biological evaluation of medical devices part 10: tests for skin sensitization
ISO 10993-23:2021, biological evaluation of medical devices - part 23: tests for skin irritation

Software Verification and Validation Testing

Software Verification and Validation Testing was conducted in accordance with IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.

Animal Study

Animal testing was not required to demonstrate safety and effectiveness of JetBoots PRO Plus

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the JetBoots PRO Plus.

Non-Clinical Testing

Device Temperature Range Testing was conducted in accordance with "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices."

(8) PERFORMANCE TESTING BENCH

The following performance bench testing was conducted:

Performance test before reliability
Reliability Bench Test Report
Performance test after reliability
Max Pressure Testing for Accuracy During Treatment
Mechanical Safety Valve Testing
Air Bladder Testing

Usability Engineering

Usability Study Report, Therabody study TG-RA-Jetboots PRO Plus

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(9) CONCLUSION:

JetBoots Pro Plus is substantially equivalent to the Primary Predicate Device and the Reference Devices in Indications for Use and technological characteristics. Though minor differences exist between the Proposed, Predicate, and Reference devices, these do not raise questions of safety and effectiveness. Therefore, Therabody's JetBoots PRO Plus is as safe, as effective, and performs as well as the Predicate and Reference Devices.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).