Navigator (FMNVG15); Navigator XL (FMNVX06)

K240105 · Forcemech International, LLC · ITI · Aug 29, 2024 · Physical Medicine

Device Facts

• Record ID: K240105
• Device Name: Navigator (FMNVG15); Navigator XL (FMNVX06)
• Applicant: Forcemech International, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Motor-driven powered wheelchair for mobility-impaired or elderly users; indoor/outdoor use. User operates via joystick controller to manage speed and direction. System includes frame, motors, Li-ion batteries, and electromagnetic brake system. Releasing joystick triggers automatic braking. Powered by 24V Li-ion battery pack; rechargeable via off-board AC charger. Provides mobility assistance; enhances independence for users with limited mobility. No clinical data; bench testing confirms safety and performance.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10993 (biocompatibility) and ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic, obstacle-climbing, EMC, and battery/charger performance) verified design specifications.

Technological Characteristics

Aluminum alloy frame; PUR armrest/cushion/backrest. Brushless DC motors (24VDC, 250W). Li-ion battery (24V 6Ah*2). Electromagnetic brake system. Joystick control. Dimensions: 980x600x940mm (FMNVG15) or 980x620x940mm (FMNVX06). Connectivity: Off-board charger (100-240V AC). Standards: ISO 7176 series, ISO 10993-5/10/23, IEC 60601-1-2.

Indications for Use

Indicated for disabled or elderly persons with mobility difficulties limited to a seated position requiring indoor and outdoor transportation.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Electrically Power Wheelchairs (K232193)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="true" type="checkbox"/> Research Use (Part 21 CFR 361, Subpart B)</div> |
| <div style="display:flex; align-items:center;"><input checked="true" type="checkbox"/> Over-The-Counter Use (21 CFR 331, Subpart C)</div> |

> 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: [phone]

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: [phone] Email: [e-mail]

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: [phone] 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:

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.

#### 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 of<br>Comparison | Subject Device | Predicate Device<br>(K232193) | Remark |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Navigator, Navigator XL | Electrically Power<br>Wheelchairs | |
| Common or Usual<br>name | Power Wheelchair | Power Wheelchair | S.E. |
| Model(s) | FMNVG15, FMNVX06 | YLB-W-0812-A01,<br>YLB-W-0812-A02,<br>YLB-W-0812-A03 | -- |
| Indications for use | It is a motor driven, indoor<br>and outdoor transportation<br>vehicle with the intended<br>use to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | It is a motor driven, indoor<br>and outdoor transportation<br>vehicle with the intended<br>use to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 4,including two front<br>wheels and two rear Wheels | 4,including two front<br>wheels and two rear Wheels | S.E |
| Function of wheels | Front wheels:driven wheels<br>suitable for rotation,<br>acceleration, retrograde<br>Rear wheels: driving<br>wheels to control the speed<br>and direction | Front wheels:driven wheels<br>suitable for rotation,<br>acceleration, retrograde<br>Rear wheels: driving<br>wheels to control the speed<br>and direction | S.E |
| | | | |
| Movement control<br>method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | S.E |
| Brake system | Intelligent electromagnetic<br>brake system | Automatic electromagnetic<br>brake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | S.E |
| Maximum safe<br>operational incline<br>degree | 6° | 6° | S.E |
| Battery charger | Off-board charger<br>Input: 100-240V, 50/60Hz,<br>Output: 24Vdc 2A | Off-board charger<br>Input: 100-240V, 50/60Hz,<br>Output: 24Vdc 2A | S.E |
| Main frame material | Aluminum Alloy | Aluminum Alloy | S.E |
| Armrest | PUR | PU | Analysis:<br>Different material<br>used for parts in |
| Back cushion | PUR | Polyester fabric | contact with user,<br>which such<br> |
| Seat cushion | PUR | rubber patch cloth and<br>Oxford fabric | differences will not<br>impact the safety and<br>effectiveness of the<br>subject device as<br>biocompatibility<br>tests are carried out<br>according to ISO<br>10993 series. |
| Overall Dimension<br>(length*width*height) | Navigator FMNVG15<br>Model: 980*600*940mm<br>Navigator XL FMNVX06<br>Model: 980*620*940mm | YLB-W-0812-A01 Model:<br>1000*660*900mm<br>YLB-W-0812-A02 Model:<br>920*550*890mm<br> | S.E |
| Folded Dimension<br>(length*width*height) | 590*370*787 mm | YLB-W-0812-A01 Model:<br>660*350*800mm<br>YLB-W-0812-A02 Model:<br>660*320*720mm<br>YLB-W-0812-A03 Model:<br>810*330*700mm | Analysis:<br>Difference on folded<br>dimension will not<br>affect safety and<br>performance of the<br>subject device. |
| Front wheel<br>size/type | 8" (203mm)<br>Non-Pneumatic tire | YLB-W-0812-A01 Model:<br>8" PU Solid tire<br>YLB-W-0812-A02 Model:<br>7" PU Solid tire<br>YLB-W-0812-A03 Model:<br>8" PU Solid tire | Analysis:<br>Different sizes and<br>materials will not<br>affect safety and<br>performance of the<br>subject device as all<br>related stability tests<br>are performed<br>according to<br>ISO 7176 |
| | | | series. |
| Rear wheel size/type | 11.8" (300mm)<br>Non-Pneumatic tire | YLB-W-0812-A01 Model:<br>12" PU Solid tire<br>YLB-W-0812-A02 Model:<br>12" Pneumatic tire<br>YLB-W-0812-A03 Model:<br>12" Pneumatic tire | Analysis:<br>Different sizes and<br>materials of rear<br>wheel will not affect<br>the safety and<br>performance of the<br>subject device as all<br>related stability tests<br>are performed<br>according to<br>standard ISO 7176<br>series. |
| Max speed forward | Up to 6 km/h | Up to 6 km/h | S.E |
| Max Speed<br>backward | 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 battery<br>rechargeable, 24VDC<br>6 Ah *2 | Li-ion battery<br>rechargeable, 25.2VDC<br>10.4Ah *2 | Analysis:<br>The battery capacity<br>will impact the travel<br>distance, which will<br>not cause new safety<br>and effectiveness<br>concerns raised. |
| Maximum<br>distance<br>of travel on the fully<br>charged battery | 16 km | 20km | Analysis:<br>Difference of the<br>parameter is caused<br>by the rated capacity<br>of battery, which<br>will not raise safe<br>and effectiveness<br>concerns |
| Motor | Brushless DC motor;<br>24VDC; 250W, 2pcs | Brushless DC motor;<br>24VDC; 150W, 2pcs | Analysis:<br>Slight difference on<br>motor power will not<br>cause different<br>performance. larger<br>power will provide<br>more driving force,<br>safety and<br>effectiveness<br>concerns raised. |
| Electronic controller | Dual Core Twin Drive<br>controller | Brushless dual-drive rocker<br>controller | S.E |
| Turning Radius | 1200 mm | 900 mm | Analysis:<br>Larger turning radius<br>will bring more<br>convenience 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 contacting<br>materials are compliance with<br>ISO10993-5, ISO10993-10 and<br>ISO 10993-23 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 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 |
|--|---------------------------|
| | |

| Item | Subject Device | Predicate Device | Results |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO7176-1 | The Static stability has been<br>determined after the testing according<br>to the ISO 7176-1, and test results<br>meet its design specification. | The Static stability has been<br>determined after the testing according<br>to the ISO 7176-1, and test results meet<br>its design specification. | S.E. |
| ISO7176-2 | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results<br>meet its design specification. | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results meet<br>its design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results<br>meet its design specification. | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results meet<br>its design specification. | S.E. |
| | | | |
| ISO7176-4 | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5. | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5. | S.E. |
| ISO7176-6 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-6. | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-6. | S.E. |
| ISO7176-7 | The seating and wheel dimensions<br>has been determined after the testing<br>according to the ISO 7176-7. | The seating and wheel dimensions<br>has been determined after the testing<br>according to the ISO 7176-7. | S.E. |
| ISO7176-8 | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8. | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8. | S.E. |
| ISO7176-9 | The test results shown that the device<br>under tests could continue to<br>function according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9. | The test results shown that the device<br>under tests could continue to function<br>according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-<br>10. | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-<br>10. | S.E. |
| ISO7176-11 | The test dummies used in the testing<br>of ISO 7176 series are meet the<br>requirements of ISO 7176-11. | The test dummies used in the testing<br>of ISO 7176 series are meet the<br>requirements of ISO 7176-11. | S.E. |
| ISO7176-13 | The coefficient of friction of test<br>surfaces has been determined, which<br>could be used in other 7176 series tests<br>involved | The coefficient of friction of test<br>surfaces has been determined, which<br>could be used in other 7176 series tests<br>involved. | S.E. |
| ISO7176-14 | All test results meet the<br>requirements in Clause 7, 8, 9, 10,<br>11, 12, 13, 14, 15, 17 of ISO 7176-<br>14. | All test results meet the<br>requirements in Clause 7, 8, 9, 10,<br>11, 12, 13, 14, 15, 17 of ISO 7176-<br>14. | S.E. |
| ISO7176-15 | The test results shown that<br>information disclosure,<br>documentation and labelling of<br>device meet the requirements of | The test results shown that<br>information disclosure,<br>documentation and labelling of<br>device 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. |

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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.