(226 days)
Not Found
No
The description details a standard electric wheelchair with a joystick control and electromagnetic brake system. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typically associated with AI/ML components in medical devices.
No
The device is a transportation vehicle designed to provide mobility for disabled or elderly persons; it does not treat or cure any condition.
No
The device is described as an indoor and outdoor transportation vehicle intended to provide mobility to disabled or elderly persons, acting as an assistive device for movement. Its components and functions relate to physical transportation, not the diagnosis of a medical condition.
No
The device description explicitly lists numerous hardware components (frame, motor, battery, controller, etc.) and describes it as a "motor driven, indoor and outdoor transportation vehicle." This is clearly a physical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Navigator and Navigator XL are described as "motor driven, indoor and outdoor transportation vehicle" intended to provide mobility to disabled or elderly individuals. They are essentially electric wheelchairs.
- Lack of Biological Specimen Analysis: The description clearly outlines the mechanical and electrical components of the device and its function in assisting movement. There is no mention of collecting or analyzing any biological specimens.
The device's purpose is to aid in physical mobility, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
0
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"
1
(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
2
3
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) |
|---|
| 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)
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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
4
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
5
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 >
6
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
Comparison | Subject Device | Predicate Device
(K232193) | Remark |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Navigator, Navigator XL | Electrically Power
Wheelchairs | |
| Common or Usual
name | 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, indoor
and outdoor transportation
vehicle with the intended
use to provide mobility to a
disabled or elderly person
limited to a seated position. | 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. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 4,including two front
wheels and two rear Wheels | 4,including two front
wheels and two rear Wheels | S.E |
| Function of wheels | Front wheels:driven wheels
suitable for rotation,
acceleration, retrograde
Rear wheels: driving
wheels to control the speed
and direction | Front wheels:driven wheels
suitable for rotation,
acceleration, retrograde
Rear wheels: driving
wheels to control the speed
and direction | S.E |
| | | | |
| Movement control
method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear
wheels | Direct drive on the rear
wheels | S.E |
| Brake system | Intelligent electromagnetic
brake system | Automatic electromagnetic
brake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | S.E |
| Maximum safe
operational incline
degree | 6° | 6° | S.E |
| Battery charger | Off-board charger
Input: 100-240V, 50/60Hz,
Output: 24Vdc 2A | Off-board charger
Input: 100-240V, 50/60Hz,
Output: 24Vdc 2A | S.E |
| Main frame material | Aluminum Alloy | Aluminum Alloy | S.E |
| Armrest | PUR | PU | Analysis:
Different material
used for parts in |
| Back cushion | PUR | Polyester fabric | contact with user,
which such
|
| Seat cushion | PUR | rubber patch cloth and
Oxford fabric | differences will not
impact the safety and
effectiveness of the
subject device as
biocompatibility
tests are carried out
according to ISO
10993 series. |
| Overall Dimension
(lengthwidthheight) | Navigator FMNVG15
Model: 980600940mm
Navigator XL FMNVX06
Model: 980620940mm | YLB-W-0812-A01 Model:
1000660900mm
YLB-W-0812-A02 Model:
920550890mm
| S.E |
| Folded Dimension
(lengthwidthheight) | 590370787 mm | YLB-W-0812-A01 Model:
660350800mm
YLB-W-0812-A02 Model:
660320720mm
YLB-W-0812-A03 Model:
810330700mm | Analysis:
Difference on folded
dimension will not
affect safety and
performance of the
subject device. |
| Front wheel
size/type | 8" (203mm)
Non-Pneumatic tire | YLB-W-0812-A01 Model:
8" PU Solid tire
YLB-W-0812-A02 Model:
7" PU Solid tire
YLB-W-0812-A03 Model:
8" PU Solid tire | Analysis:
Different sizes and
materials will not
affect safety and
performance of the
subject device as all
related stability tests
are performed
according to
ISO 7176 |
| | | | series. |
| Rear wheel size/type | 11.8" (300mm)
Non-Pneumatic tire | YLB-W-0812-A01 Model:
12" PU Solid tire
YLB-W-0812-A02 Model:
12" Pneumatic tire
YLB-W-0812-A03 Model:
12" Pneumatic tire | Analysis:
Different sizes and
materials of rear
wheel will not affect
the safety and
performance of the
subject device as all
related stability tests
are performed
according to
standard ISO 7176
series. |
| Max speed forward | Up to 6 km/h | Up to 6 km/h | S.E |
| Max Speed
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
rechargeable, 24VDC
6 Ah *2 | Li-ion battery
rechargeable, 25.2VDC
10.4Ah *2 | Analysis:
The battery capacity
will impact the travel
distance, which will
not cause new safety
and effectiveness
concerns raised. |
| Maximum
distance
of travel on the fully
charged battery | 16 km | 20km | Analysis:
Difference of the
parameter is caused
by the rated capacity
of battery, which
will not raise safe
and effectiveness
concerns |
| Motor | Brushless DC motor;
24VDC; 250W, 2pcs | Brushless DC motor;
24VDC; 150W, 2pcs | Analysis:
Slight difference on
motor power will not
cause different
performance. larger
power will provide
more driving force,
safety and
effectiveness
concerns raised. |
| Electronic controller | Dual Core Twin Drive
controller | Brushless dual-drive rocker
controller | S.E |
| Turning Radius | 1200 mm | 900 mm | Analysis:
Larger turning radius
will bring more
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 |
7
8
9
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 | ||
| materials are compliance with | |||
| ISO10993-5, ISO10993-10 and | |||
| ISO 10993-23 requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| 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 | ||
| determined after the testing according | |||
| to the ISO 7176-1, and test results | |||
| meet its design specification. | The Static stability has been | ||
| determined after the testing according | |||
| to the ISO 7176-1, and test results meet | |||
| its design specification. | S.E. | ||
| ISO7176-2 | The dynamic stability has been | ||
| determined after the testing according | |||
| to the ISO 7176-2, and test results | |||
| meet its design specification. | The dynamic stability has been | ||
| determined after the testing according | |||
| to the ISO 7176-2, and test results meet | |||
| its design specification. | S.E. | ||
| ISO7176-3 | The effectiveness of brakes has been | ||
| determined after the testing according | |||
| to the ISO 7176-3, and test results | |||
| meet its design specification. | The effectiveness of brakes has been | ||
| determined after the testing according | |||
| to the ISO 7176-3, and test results meet | |||
| its design specification. | S.E. | ||
| ISO7176-4 | The theoretical distance range has | ||
| been determined after the testing | |||
| according to the ISO 7176-4, and test | |||
| results meet its design specification. | The theoretical distance range has | ||
| been determined after the testing | |||
| according to the ISO 7176-4, and test | |||
| results meet its design specification. | S.E. | ||
| ISO7176-5 | The dimensions, mass has been | ||
| determined after the testing according | |||
| to the ISO 7176-5. | The dimensions, mass has been | ||
| determined after the testing according | |||
| to the ISO 7176-5. | S.E. | ||
| ISO7176-6 | The dimensions, mass has been | ||
| determined after the testing according | |||
| to the ISO 7176-6. | The dimensions, mass has been | ||
| determined after the testing according | |||
| to the ISO 7176-6. | S.E. | ||
| ISO7176-7 | The seating and wheel dimensions | ||
| has been determined after the testing | |||
| according to the ISO 7176-7. | The seating and wheel dimensions | ||
| has been determined after the testing | |||
| according to the ISO 7176-7. | S.E. | ||
| ISO7176-8 | All test results meet the | ||
| requirements in Clause 4 of ISO | |||
| 7176-8. | All test results meet the | ||
| requirements in Clause 4 of ISO | |||
| 7176-8. | S.E. | ||
| ISO7176-9 | The test results shown that the device | ||
| under tests could continue to | |||
| function according to manufacturer's | |||
| specification after being subjected to | |||
| each of the tests specified in Clause 8 | |||
| of ISO 7176-9. | The test results shown that the device | ||
| under tests could continue to function | |||
| according to manufacturer's | |||
| specification after being subjected to | |||
| each of the tests specified in Clause 8 | |||
| of ISO 7176-9 | S.E. | ||
| ISO7176-10 | The obstacle-climbing ability of | ||
| device has been determined after the | |||
| testing according to the ISO 7176- |
-
| The obstacle-climbing ability of
device has been determined after the
testing according to the ISO 7176-
10. | S.E. |
| ISO7176-11 | The test dummies used in the testing
of ISO 7176 series are meet the
requirements of ISO 7176-11. | The test dummies used in the testing
of ISO 7176 series are meet the
requirements of ISO 7176-11. | S.E. |
| ISO7176-13 | The coefficient of friction of test
surfaces has been determined, which
could be used in other 7176 series tests
involved | The coefficient of friction of test
surfaces has been determined, which
could be used in other 7176 series tests
involved. | S.E. |
| ISO7176-14 | All test results meet the
requirements in Clause 7, 8, 9, 10,
11, 12, 13, 14, 15, 17 of ISO 7176-
14. | All test results meet the
requirements in Clause 7, 8, 9, 10,
11, 12, 13, 14, 15, 17 of ISO 7176-
14. | S.E. |
| ISO7176-15 | The test results shown that
information disclosure,
documentation and labelling of
device meet the requirements of | The test results shown that
information disclosure,
documentation and labelling of
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. |
10
11
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.