The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

AI/ML Overview

The provided document, a 510(k) Pre-market Notification for the Navigator and Navigator XL powered wheelchairs, does not describe a study involving an AI/Machine Learning device, expert adjudication, or complex ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for medical devices like powered wheelchairs.

Therefore, many of the requested details, such as those related to AI/ML performance, human readers, training/test sets, and expert consensus for ground truth, are not applicable to this document.

However, I can extract the acceptance criteria and the "device performance" in terms of meeting those criteria.

Here's a breakdown of the information that is available in the document, formatted to the extent possible according to your request:

Acceptance Criteria and Device Performance (for a Powered Wheelchair)

This section describes the performance evaluation of the Forcemech International LLC Navigator and Navigator XL powered wheelchairs against established international standards for wheelchairs. The study's purpose was to demonstrate substantial equivalence to a predicate device (K232193) by meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various parts of the ISO 7176 series of standards and ISO 10993 series for biocompatibility. The reported device performance is that the device meets or complies with these standards.

Acceptance Criteria (Standard & Clause)	Specific Performance Requirement (Implicit from Standard)	Reported Device Performance
Biocompatibility
ISO 10993-5: 2009	Tests For In Vitro Cytotoxicity	All user directly contacting materials are compliant.
ISO 10993-10: 2021	Tests For Irritation And Skin Sensitization	All user directly contacting materials are compliant.
ISO 10993-23: 2021	Tests For Irritation	All user directly contacting materials are compliant.
Performance (ISO 7176 Series)
ISO 7176-1: 2014	Determination of static stability	Test results meet its design specification.
ISO 7176-2: 2017	Determination of dynamic stability of Powered Wheelchairs	Test results meet its design specification.
ISO 7176-3: 2012	Determination of effectiveness of brakes	Test results meet its design specification.
ISO 7176-4: 2008	Determination of theoretical distance range	Test results meet its design specification.
ISO 7176-5: 2008	Determination of overall dimensions, mass and manoeuvring space	Dimensions and mass determined after testing.
ISO 7176-6: 2018	Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs	Dimensions and mass determined after testing (likely refers to speeds, acceleration, deceleration).
ISO 7176-7	Measurement of seating and wheel dimensions	Seating and wheel dimensions determined after testing.
ISO 7176-8: 2014	Requirements and test methods for static, impact and fatigue strengths	All test results meet the requirements in Clause 4.
ISO 7176-9: 2009	Climatic tests for Powered Wheelchairs	Device continued to function according to manufacturer's specification after tests.
ISO 7176-10: 2008	Determination of obstacle-climbing ability of electrically powered wheelchairs	Obstacle-climbing ability determined after testing.
ISO 7176-11: 2012	Test dummies	Test dummies used meet the requirements of ISO 7176-11.
ISO 7176-13: 1989	Determination of coefficient of friction of test surfaces	Coefficient of friction of test surfaces determined.
ISO 7176-14: 2008	Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods	All test results meet requirements in Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17.
ISO 7176-15: 1996	Requirements for information disclosure, documentation and labeling	Information disclosure, documentation, and labeling meet requirements.
ISO 7176-16: 2012	Resistance to ignition of postural support devices	Performance meets the requirements.
ISO 7176-21: 2009	Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers	EMC performance results meet the requirements.
ISO 7176-25: 2013	Batteries and chargers for powered wheelchairs	Performance of batteries and charger meet requirements in Clause 5 and 6.
Electrical Safety
IEC 60601-1-2 (related to EMC)	Electromagnetic Compatibility	Compliant. (Note: ISO 7176-21 overlaps here primarily).
Labeling
FDA Regulatory	General labeling requirements	Conforms to FDA Regulatory.

The document also provides specific performance values for some parameters, as compared to the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "comparison elements" that need to demonstrate substantial equivalence:

Parameter	Acceptance Criteria (implied, if different from predicate, must be shown safe/effective)	Reported Device Performance	Predicate Device Performance
Braking distance	≤1.5 m	≤1.5 m	≤1.5 m
Max safe operational incline degree	6°	6°	6°
Battery (Type)	Li-ion battery, rechargeable	Li-ion battery, rechargeable	Li-ion battery, rechargeable
Max speed forward	Up to 6 km/h	Up to 6 km/h	Up to 6 km/h
Max Speed backward	Less than 3 km/h (0.8 m/s)	Less than 3 km/h (0.8 m/s)	Less than 3 km/h (0.8 m/s)
Max loading weight	120 Kg	120 Kg	120 Kg
Maximum obstacle climbing	40 mm	40 mm	40 mm

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document describes non-clinical testing performed on the device itself. For each standard mentioned (e.g., ISO 7176 series, ISO 10993 series), tests are conducted on a statistically appropriate number of units or materials according to the specific standard's requirements. This is not a patient-based test set but rather a device-based test set. The exact number of units tested for each standard is not specified in this summary but would be detailed in the full test reports.
Data Provenance: The tests are "non-clinical tests" conducted to verify compliance with design specifications and substantially equivalence. The location of testing is implicitly China, given the applicant's contact person is in Shanghai, China, and the submission correspondent is also from Shanghai, China. The data would be prospective in the sense that the manufacturer specifically conducted these tests on their device models.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical device performance study against engineering and safety standards, not a diagnostic AI/ML study requiring expert radiologists for image interpretation or clinical ground truth. The "ground truth" here is the adherence to the published ISO/IEC standards, which are developed by international expert committees through a consensus process.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study. The "adjudication" is met by passing the specified tests against the published standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This document explicitly states: "No clinical study is included in this submission." This type of study is for evaluating human performance, typically in diagnostic imaging, and is not relevant for a powered wheelchair's non-clinical safety and performance testing.

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

Not applicable. This is a medical device (powered wheelchair), not an AI/ML algorithm. The performance evaluation is for the physical device and its electrical/mechanical systems.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is adherence to well-defined, internationally recognized engineering and safety standards (ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC). These standards dictate specific test methods and acceptance criteria that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI/ML training set.

Summary

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

August 29, 2024

Forcemech International LLC % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China

Re: K240105

Trade/Device Name: Navigator (FMNVG15); Navigator XL (FMNVX06) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 9, 2024 Received: August 9, 2024

Dear Jarvis Wu:

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.

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"

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(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 OS 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.

Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Indications for Use

510(k) Number (if known) K240105

Device Name Navigator (model: FMNVG15) Navigator XL (model: FMNVX06)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Research Use (Part 21 CFR 361, Subpart B)
Over-The-Counter Use (21 CFR 331, Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K240105

Document Prepared Date: 2024/1/8

Applicant: A. Forcemech International LLC Address: 4111 Rice Drier Road #1H, Pearland,TX,77581,USA. Contact Person: David Ou Tel: +1 281-881-6097

Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com

Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com

B. Device:

Trade Name: Navigator, Navigator XL Common Name: Powered wheelchair Models: FMNVG15, FMNVX06

Regulatory Information Classification Name: Powered Wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine

C. Predicate device:

510K number: K232193 Device Name: Electrically Power Wheelchairs

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Forcemech International LLC 4111 Rice Drier Road #1H, Pearland,TX,77581,USA. Models: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03

Yurob Rehabilitation Medical Co.,Ltd.

D. Indications for use of the device:

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

E. Device Description:

F. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A 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 Irritation And > Skin Sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation A
ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes A
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range
ISO 7176-5. Second edition 2008-06-01. Wheelchairs Part 5: Determination of overall > dimensions, mass and manoeuvring space
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7, Wheelchairs Part 7: Measurement of seating and wheel dimensions A
ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and >

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fatigue strengths

ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices.
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate Device

Elements ofComparison	Subject Device	Predicate Device(K232193)	Remark
Trade Name	Navigator, Navigator XL	Electrically PowerWheelchairs
Common or Usualname	Power Wheelchair	Power Wheelchair	S.E.
Model(s)	FMNVG15, FMNVX06	YLB-W-0812-A01,YLB-W-0812-A02,YLB-W-0812-A03	--
Indications for use	It is a motor driven, indoorand outdoor transportationvehicle with the intendeduse to provide mobility to adisabled or elderly personlimited to a seated position.	It is a motor driven, indoorand outdoor transportationvehicle with the intendeduse to provide mobility to adisabled or elderly personlimited to a seated position.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4,including two frontwheels and two rear Wheels	4,including two frontwheels and two rear Wheels	S.E
Function of wheels	Front wheels:driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: drivingwheels to control the speedand direction	Front wheels:driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: drivingwheels to control the speedand direction	S.E

Movement controlmethod	By Joystick control	By Joystick control	S.E
Driving system	Direct drive on the rearwheels	Direct drive on the rearwheels	S.E
Brake system	Intelligent electromagneticbrake system	Automatic electromagneticbrake system	S.E
Braking distance	≤1.5 m	≤1.5 m	S.E
Maximum safeoperational inclinedegree	6°	6°	S.E
Battery charger	Off-board chargerInput: 100-240V, 50/60Hz,Output: 24Vdc 2A	Off-board chargerInput: 100-240V, 50/60Hz,Output: 24Vdc 2A	S.E
Main frame material	Aluminum Alloy	Aluminum Alloy	S.E
Armrest	PUR	PU	Analysis:Different materialused for parts in
Back cushion	PUR	Polyester fabric	contact with user,which such
Seat cushion	PUR	rubber patch cloth andOxford fabric	differences will notimpact the safety andeffectiveness of thesubject device asbiocompatibilitytests are carried outaccording to ISO10993 series.
Overall Dimension(lengthwidthheight)	Navigator FMNVG15Model: 980600940mmNavigator XL FMNVX06Model: 980620940mm	YLB-W-0812-A01 Model:1000660900mmYLB-W-0812-A02 Model:920550890mm	S.E
Folded Dimension(lengthwidthheight)	590370787 mm	YLB-W-0812-A01 Model:660350800mmYLB-W-0812-A02 Model:660320720mmYLB-W-0812-A03 Model:810330700mm	Analysis:Difference on foldeddimension will notaffect safety andperformance of thesubject device.
Front wheelsize/type	8" (203mm)Non-Pneumatic tire	YLB-W-0812-A01 Model:8" PU Solid tireYLB-W-0812-A02 Model:7" PU Solid tireYLB-W-0812-A03 Model:8" PU Solid tire	Analysis:Different sizes andmaterials will notaffect safety andperformance of thesubject device as allrelated stability testsare performedaccording toISO 7176
			series.
Rear wheel size/type	11.8" (300mm)Non-Pneumatic tire	YLB-W-0812-A01 Model:12" PU Solid tireYLB-W-0812-A02 Model:12" Pneumatic tireYLB-W-0812-A03 Model:12" Pneumatic tire	Analysis:Different sizes andmaterials of rearwheel will not affectthe safety andperformance of thesubject device as allrelated stability testsare performedaccording tostandard ISO 7176series.
Max speed forward	Up to 6 km/h	Up to 6 km/h	S.E
Max Speedbackward	Less than 3 km/h (0.8 m/s)	Less than 3 km/h (0.8 m/s)	S.E
Max loading weight	120 Kg	120 Kg	S.E
Battery	Li-ion batteryrechargeable, 24VDC6 Ah *2	Li-ion batteryrechargeable, 25.2VDC10.4Ah *2	Analysis:The battery capacitywill impact the traveldistance, which willnot cause new safetyand effectivenessconcerns raised.
Maximumdistanceof travel on the fullycharged battery	16 km	20km	Analysis:Difference of theparameter is causedby the rated capacityof battery, whichwill not raise safeand effectivenessconcerns
Motor	Brushless DC motor;24VDC; 250W, 2pcs	Brushless DC motor;24VDC; 150W, 2pcs	Analysis:Slight difference onmotor power will notcause differentperformance. largerpower will providemore driving force,safety andeffectivenessconcerns raised.
Electronic controller	Dual Core Twin Drivecontroller	Brushless dual-drive rockercontroller	S.E
Turning Radius	1200 mm	900 mm	Analysis:Larger turning radiuswill bring moreconvenience for the
			use environment. All
			relevant tests have
			been performed
			according to
			standards ISO 7176
			series, the difference
			will not raise any
			new safety and
			effectiveness
			concerns.
Maximum obstacle
climbing	40 mm	40 mm	S.E

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I. Difference analysis

The design and technological characteristics of the Power Wheelchair Navigator XL are similar to the predicates chosen. There are minor differences between the devices including Folded Dimension, Front & Rear wheel size/type, Battery, Maximum distance of travel on the fully charged battery, Motor and Turning Radius. All of the parameter with difference have been tested according to ISO 7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Power Wheelchair Navigator XL are substantially equivalent (SE) to The Power Wheelchair (K232193).

	Table 2 Safetv comparison

Item	Subject Device	Predicate Device	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5, ISO10993-10 andISO 10993-23 requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	S.E.
EMC	ISO7176-21 & IEC 60601-1-2	ISO7176-21	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Label and labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

	Table 3 Safety comparison

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Forcemech International LLC 4111 Rice Drier Road #1H Pearland TX 77581 USA

J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06), are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K232193.

Regulation Number and Section

N/A

Item	Subject Device	Predicate Device	Results
ISO7176-1	The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification.	The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test results meetits design specification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test resultsmeet its design specification.	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results meetits design specification.	S.E.
ISO7176-3	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test resultsmeet its design specification.	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test results meetits design specification.	S.E.

ISO7176-4	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5.	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5.	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-6.	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-6.	S.E.
ISO7176-7	The seating and wheel dimensionshas been determined after the testingaccording to the ISO 7176-7.	The seating and wheel dimensionshas been determined after the testingaccording to the ISO 7176-7.	S.E.
ISO7176-8	All test results meet therequirements in Clause 4 of ISO7176-8.	All test results meet therequirements in Clause 4 of ISO7176-8.	S.E.
ISO7176-9	The test results shown that the deviceunder tests could continue tofunction according to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9.	The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9	S.E.
ISO7176-10	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10.	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10.	S.E.
ISO7176-11	The test dummies used in the testingof ISO 7176 series are meet therequirements of ISO 7176-11.	The test dummies used in the testingof ISO 7176 series are meet therequirements of ISO 7176-11.	S.E.
ISO7176-13	The coefficient of friction of testsurfaces has been determined, whichcould be used in other 7176 series testsinvolved	The coefficient of friction of testsurfaces has been determined, whichcould be used in other 7176 series testsinvolved.	S.E.
ISO7176-14	All test results meet therequirements in Clause 7, 8, 9, 10,11, 12, 13, 14, 15, 17 of ISO 7176-14.	All test results meet therequirements in Clause 7, 8, 9, 10,11, 12, 13, 14, 15, 17 of ISO 7176-14.	S.E.
ISO7176-15	The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of	The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO	S.E.
4111 Rice Drier Road #1H, Pearland, TX, 77581,USA.
	ISO 7176-15.	7176-15.
ISO7176-16	The performance of resistance to ignition meet the requirements of ISO 7176-16.	The performance of resistance to ignition meet the requirements of ISO 7176-16.	S.E.
ISO 7176-21	The EMC performance results meet the requirements of ISO 7176-21.	The EMC performance results meet the requirements of ISO 7176-21.	S.E.
ISO7176-25	The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25.	The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25.	S.E.