Predicate Devices

Reference Devices

YAMAHA MOTOR CO., LTD. JWX-2 (K140204)

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical components of a powered wheelchair conversion kit and does not mention any AI or ML capabilities.

Therapeutic

Yes
The device is described as being for "medical purposes" to provide mobility for disabled persons, which aligns with the definition of a therapeutic device.

Diagnostic

No

Explanation: The device is a powered wheelchair conversion kit intended to increase mobility for disabled persons, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components like drive units, a controller, battery, and battery charger, which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 JWX-1 PLUS is a powered wheelchair conversion kit. Its function is to provide mobility and propulsion for a disabled person. It does not interact with or analyze any biological specimens.
Intended Use: The intended use is to assist a disabled person with mobility, not to diagnose or monitor a medical condition through the analysis of biological samples.

The description clearly indicates that this is a mechanical and electrical device designed to enhance the functionality of a manual wheelchair for mobility purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device JWX-1 PLUS( NAVIGO 24" ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Product codes

ITI

Device Description

The JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is an add-on drive for wheelchairs. The JWX-1 PLUS turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.

Yamaha Ni-MH battery JWB2 and Yamaha Li-ion be used for the device. They are recharged can be charged also on the wheelchair condition. ESB1 does not supply the driving the charging to prevent the wheelchair to move.

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 Testing:
The device JWX-1 PLUS( NAVIGO 16" /NAVIGO 24" ) was tested with the following standards:
ISO 7176–1·1999 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2001 ,Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3 Third edition 2012-12-15. Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4 Third edition 2008-10-01, Wheelchairs – Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-6 Second edition 2001-10-01, Wheelchairs – Part 6: Determination of maximum speed, acceleration of electric wheelchairs
ISO 7176-8:1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-11 Second edition 2012-12-01, Wheelchairs - Part 11: Test dummies
ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15 First edition 1996-11-15, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-21 Second edition 2009-04-01. Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2000, Wheelchairs - Part 22: Set-up procedures
IFC 62304 edition 10 2015-06 Medical device software - Software life cycle processes.
ISO 14971 Third Edtion 2019-12, Medical devices - Application of risk management to medical devices
ISO 10993-1 Fifth edition 2018-10. Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10 Third edition 2010-08-01. Biological evaluation of medical devices -- Part 10: Tests for iriitation and skin sensitization
IEC 62133-1 Edition 1.0 2017-02, 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 1: Nickel systems
IEC 62133-2 Edition 1.0: 2017-02, 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
IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment – part 1–2: general requirements for safety – collateral standard: electromagnetic compatibility – requirements and tests (edition2:2001 with amendment 1:2004) (aam/ansi/iec 60601–1–2:2001 with amendment 1:2004 is the u.s..(General I (QS/RM))
IEC 60335-2-29 Ed. 5.0: 2016 (b) , Household and similar electrical appliances – Safety – Part 2–29:Particular requirements for battery chargers

Key results from comparison table:

Braking technologies: Performance tests of parking brake, braking distance etc. passed. Test results conform to our intended use.
Speed, acceleration, deceleration: Performance tests of maximum forward/reverse/ downhill speed etc. passed. Test results conform to our intended use.
User interface: Performance tests of electrical safety passed. Test results conform to our intended use.
User interface 2 (For attendant / assistant): Performance tests of electrical safety passed. Test results conform to our intended use.
Max Safe Slope: Performance tests of Max Safe Slope passed. Test results conform to our intended use.
Max Range per Charge: Performance tests of Max Range per Charge passed. Test results conform to our intended use.
Battery: Performance tests of battery electrical safety passed. Test results conform to our intended use.
Battery Charger: Performance tests of battery charger for electrical safety, EMC passed. Test results conform to our intended use.
Wheel Size: Performance tests of wheel chair mechanical safety with 24/16 inch wheel passed. Test results conform to our intended use.
Regenerative Brake: Performance tests of braking system etc. passed. Test results conform to our intended use.
Down Slope Speed Regulation: Performance tests of downhill speed passed. Test results conform to our intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Alber GmbH e-fix E35/E36 (K161241)

Reference Device(s)

YAMAHA MOTOR CO., LTD. JWX-2 (K140204)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 21, 2021

Yamaha Motor CO., LTD. Mikio Saitou Official Correspondent 2500 Shingai Iwata, Shizuoka 438-8501 Japan

Re: K203806

Trade/Device Name: JWX-1 Plus (Navigo 16"/Navigo 24") Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 1, 2021 Received: March 1, 2021

Dear Mikio Saitou:

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 (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 located 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.

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

1

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/cdrl-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 Dean, PhD Assistant Director, Acute Injury Device Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203806

Device Name JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" )

Indications for Use (Describe)

The device JWX-1 PLUS( NAVIGO 24" ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Submitter information

| Manufacture Name: | YAMAHA MOTOR CO., LTD.
2500 Shingai, Iwata
Shizuoka 438-8501, Japan |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michiyo YAMAZAKI, General Manager
JW Wheelchairs Division, Smart Power Vehicle Business Unit
YAMAHA MOTOR CO., LTD.
Tel: +81-538-32-2106
Fax: +81-538-38-9217
E-mail: yamazakim@yamaha-motor.co.jp |
| 2. Date Prepared | December 1, 2020 |
| 3. Device | |
| Type in common name: | Electric add-on drive for wheelchairs |
| Name: | JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) |
| Classification Name: | Wheelchair, Powered (21 CFR 890.3860), Class II |
| Product Code: | ITI |
| Device Structure: | Right Drive Unit
Left Drive Unit
Controller
Battery
Battery Charger |
| 4. Predicate Device: | Alber GmbH e-fix E35/E36 (K161241)
YAMAHA MOTOR CO., LTD. JWX-2 (K140204) |
| 5. Device Description | The JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is an add-on drive for wheelchairs. The JWX-1 PLUS turns a
manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to prov
a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and
flexibility |

The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.

purposes to provide

Yamaha Ni-MH battery JWB2 and Yamaha Li-ion be used for the device. They are recharged can be charged also on the wheelchair condition. ESB1 does not supply the driving the charging to prevent the wheelchair to move.

1. Indications for use
  The device JWX-1 PLUS( NAVIGO 24″ ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can't walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the wheelchair and increase mobility and flexibility.

Comparison to Predicate Devices

The device has the similar technological characteristics as the predicate device. The microprocessors in both devices control the electrical current from the rechargeable batteries to the wheel-in motors in response to the user's joystick operations. See COMPARISON TABLE below.

4

Non-Clinical Testing

The device JWX-1 PLUS( NAVIGO 16" /NAVIGO 24" ) was tested with the following standards:

ISO 7176–1·1999 Wheelchairs - Part 1: Determination of static stability

ISO 7176-2:2001 ,Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs

ISO 7176-3 Third edition 2012-12-15. Wheelchairs - Part 3: Determination of effectiveness of brakes

ISO 7176-4 Third edition 2008-10-01, Wheelchairs – Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

ISO 7176-6 Second edition 2001-10-01, Wheelchairs – Part 6: Determination of maximum speed, acceleration of electric wheelchairs

ISO 7176-8:1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths

ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs

ISO 7176-11 Second edition 2012-12-01, Wheelchairs - Part 11: Test dummies

ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods

ISO 7176-15 First edition 1996-11-15, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

ISO 7176-21 Second edition 2009-04-01. Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

ISO 7176-22:2000, Wheelchairs - Part 22: Set-up procedures

IFC 62304 edition 10 2015-06 Medical device software - Software life cycle processes.

ISO 14971 Third Edtion 2019-12, Medical devices - Application of risk management to medical devices

ISO 10993-1 Fifth edition 2018-10. Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10 Third edition 2010-08-01. Biological evaluation of medical devices -- Part 10: Tests for iriitation and skin sensitization

IEC 62133-1 Edition 1.0 2017-02,

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 1: Nickel systems

5

IEC 62133-2 Edition 1.0: 2017-02,

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

IEC 60601-1-2 Edition 4.0 2014-02,

medical electrical equipment – part 1–2: general requirements for safety – collateral standard: electromagnetic compatibility – requirements and tests (edition2:2001 with amendment 1:2004) (aam/ansi/iec 60601–1–2:2001 with amendment 1:2004 is the u.s..(General I (QS/RM))

IEC 60335-2-29 Ed. 5.0 :2016 (b) , Household and similar electrical appliances – Safety – Part 2–29:Particular requirements for battery chargers

9. Summary

The device JWX-1 PLUS( NAVIGO 16" ) has the same intended use and similar technological characteristics as the predicate device. The device does not raise any new questions of safety or effectiveness. The device is substantially equivalent to the predicate device.

6

| Comparison table e-fix E35/E36 versus JWX-2 versus
JWX-1 PLUS(NAVIGO 16"/NAVIGO 24")
(Same performance are indicated by boldface.) | | | note:
The primary predicate device is e-fix E35/E36(K161241).
The reason why JWX-2(K140204) as complementary device is used in the Substantial Equivalence
Discussion is that NI-MH, LI battery registered in the K140204 device will be used in the subject
device. The NI-MH, LI battery are compatible to the subject devices. | |
|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | primary predicate device | complementary predicate device | Subject Device | Rationale |
| | e-fix E35 | JWX-2 | JWX-1 PLUS
(NAVIGO 16"/NAVIGO 24") | |
| | e-fix E36 | K140204 | | |
| | K161241 | | | |
| Intended Use | The e-fix is an add-on drive for
wheelchairs. The e-fix E35/E36 turns a
manually propelled wheelchair into a
powered wheelchair. It is intended for
medical purposes to provide a means for a
disabled person to take over the
propulsion of the wheelchair and increase
mobility and flexibility. | The device JWX-2 is a Power Assist
Wheelchair Conversion Kit and suitable for
the manual wheelchair users who are
limited in their field of activities because
of their physical conditions. The
device can expand their field of activities
by assisting their wheelchair operating
force. | The device JWX-1 PLUS is a Powered
Wheelchair Conversion Kit and suitable for a
disabled person who can not walk or have
restrictions on walking.
It is intended for medical purposes to provide a
means for a disabled person to take over the
propulsion of the wheelchair and increase
mobility and flexibility. | On safety and effectiveness view point, the subject device is as
same as the predicate devices. Because it is equal to other
ones at the concept of expanding driver's mobility by add-on
device. |
| Total Weight | 18.9kg(Li-ion) | 17 kg (Ni-MH)
17.7kg (Li-ion) | 20 kg (Ni-MH)/24", 18 kg (Ni-MH)/16"
21kg (Li-ion)/24", 19kg (Li-ion)/16" | The Subject Device is similar weight.
So it has no negative influence on the safety of the device. |
| Braking
technologies | Manual parking brake
Electromotive brake
Electromechanical brake | Manual parking brake
Electromotive brake | Manual parking brake
Electromotive brake
Electromechanical brake | The subject device has similar breaking means as e-fix E35/E36. So it
has no negative influence on the safety of the device.

Report Page:
18-38 to 18-47 10 Propulsion and braking system
17-75 8.12 Brakes
Performance tests of parking brake, braking distance etc. passed.
Test results conform to our intended use. |
| Speed, acceleration, deceleration | Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the joystick. | Microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the hand-rim. | Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the joystick. | The subject device has similar speed control means as e-fix E35/E36. So it has no negative influence on the safety of the device.
Report Page:
18-21 8.1.4 Maximum Downhill speed
18-26 8.1.8 Maximum speed
18-42 10.2.1(a) Requirement
17-72 5.3. Wheel Chair
Performance tests of maximum forward/reverse/ downhill speed etc. passed.
Test results conform to our intended use. |
| User interface | Joystick & push buttons | Hand-rim | Joystick & Toggle switch | On the subject device and e-fix E35/E36, joystick controls the direction and motor start/stop. Compare to e-fix E35/E36, the defferences between JWX-1 PLUS (See Owner's Manual 4.2 page 13-55 and 4.3 page 13-59) and E35/36 (User Manual page 13-139) are power on/off and speed setting means. JWX-1 PLUS uses toggle switch that can be operated even by people with weak hands. Toggle switch is easier to operate than push button or dial because it dosn't need complicated move or force.
The toggle switch has no influence on the safety of the powered propulsion.
Report Page:
17-64 TEST REPORT PPP31025:2011A
18-51 12 electrical system
Performance tests of electrical safety passed. Test results conform to our intended use. |
| User interface 2
(For attendant / assistant) | Lever, Dial and Toggle switch | Dial and Push switch | | User interface 2 is the input device for attendant.
JWX-1 PLUS's power on/off switch (See Owner's Manual 6. page 13-65) is as same as the push button of E35/E36 (See User Manual Intuitive attendant control page 13-180).
Both E35/E36 and JWX-1 PLUS have a speed control dial. On JWX-1 PLUS, there are some distance from glip to dial, so there are less misoperation during operation.
E35/E36 has a switch to toggle the direction forward and backward, and a lever to toggle motor start and stop. Whereas JWX-1 PLUS has a button to start or stop the motor for each forward and backward direction.
Input means are slight different but functions are almost same. Motor on/off switches of JWX-1 PLUS are separated and different sizes in each direction so there are less confusion of the direction.
So it has no negative influence on the safety of the device.
Report Page:
17-64 TEST REPORT PPP31025:2011A
18-51 12 electrical system
Performance tests of electrical safety passed. Test results conform to our intended use. |

7

8

Max. User Weight	Speed Range with Power Assist	Max Safe Slope	Max Range per Charge
120kg	up to 6Km/h	up to 20%	up to 16km
(up to 13miles with the
optionally available high
capacity battery pack)	DC Brushless Motor	DC36V 110W × 2
160kg	up to 6Km/h	up to 15%	40km & above (Li-ion)
20km & above (Ni-MH)	AC servomotor
(DC Brushless Motor)	DC36V 150W × 2
130kg	up to 6Km/h	up to 6 degrees (up to 10%)	16km & above (Ni-MH)/24"
30km & above (Li-ion)/24"
15km & above (Ni-MH)/16"
25km & above (Li-ion)/16"	AC servomotor
(DC Brushless Motor)	30mins rated DC24V 110W x 2
125kg/24", 100kg/16"
The subject device has a lower user weight
capacity and has no negative influence on the
safety of the device.	Same

Report Page:
18-21 8.1.4 Maximum Downhill speed
18-26 8.1.8 Maximum speed
18-42 10.2.1(a) Requirement
17-72 5.3. Wheel Chair
Performance tests of electrical safety passed. Test
results conform to our intended use. | up to 6 degrees (up to 10%)
The subject device has lower climbing capacity
but it does not adversely affect safety or
effectiveness of the subject device. | Compare to e-fix E35/E36, The Subject Device has less range.
However, it has no negative influence on the safety of the
device

Report Page:
18-20 to 18-22 8.1.2 Ability to climb rated slope.
Performance tests of Max Safe Slope passed. Test results
conform to our intended use. | Compare to e-fix E35/E36, the Subject Device has more range.
However, it has no negative influence on the safety of the
device.

Report Page:
18-27 8.1.9 Distance range
18-61 13.2 q)
Performance tests of Max Range per Charge passed. Test
results conform to our intended use. | Same

The differences in motor performance do not affect safety of
the subject device. |

9

Battery	Battery Charger	Battery Mount
Type: Li-ion
Capacity: 36V 6.0Ah	Input: 100V-240V AC 50-60Hz 1.35A
Output: 45V 1.5A DC	Holder fixed to frame with Velcro strap.	K161241
Type: Ni-MH(Dry)
Capacity: 24V 6.7Ah(Nom.)	Ni-MH specific charger
Input: 100-240V AC 50-60Hz 1.8A
Output: 29V 2.6A DC
(JWC-2)	Holder is in the bag, and the bag is fixed to frame with Velcro strap.	K140204
Type: Li-ion(Dry)
Capacity: 25V11.8Ah(Nom.)
*Selectable	Li-ion specific charger
Input: 100-240V AC 50-60Hz 2A
Output: 29.2V 3A DC
(ESC1)	Holder is in the bag, and the bag is fixed to frame with Velcro strap.	Subject Device
Type: Ni-MH(Dry)
Capacity: 24V 6.7Ah(Nom.)	Ni-MH & Li-ion common charger
Input: 100-240V AC 50-60Hz 1.1A
Output: 29V 2.6A DC (for Ni-MH)
29.2V 3A DC (for Li-ion)
(ESC3)	Battery mount way is the same as JWX-2 one that has already recognized at K140204.
Type: Li-ion(Dry)
Capacity: 25V11.8Ah(Nom.)
*Selectable	JWC-2 is the charger for Ni-MH battery. ESC1 is the charger
for Li-ion battery. Both chargers has discontinued so the new
ESC3 charger is unified two chargers, (See EMC TEST REPORT
Appendix 2 page 17-246).
ESC3 can charge both Ni-MH and Li-ion.
Charging way of each battery is different. When charging Ni-MH
battery, it is put on the receptacle on the body of the charger.
When charging Li-ion battery, it is connected by charging cable
from the charger. These manners are as same as each previous
charger, therefore it is hard to misunderstand the usage of it.
So it has no negative influence on the safety of the device.
The Subject Device's batteries are the same as JWX-2 ones that
has already recognized at K140204.	Report Page:
18-51 to 18-53 12.1 General requirement
17-189 EMC TEST REPORT
17-287 TEST RPORT IEC60335-2-29
Performance tests of battery charger for electrical safety, EMC
passed. Test results conform to our intended use.
Report Page:
10-24 to 10-47 1. INTRODUCTION
17-84 to 17-186 TEST REPORT IEC62133-2
Performance tests of battery electrical safety passed. Test results
conform to our intended use.

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| Wheel Size | Tire | Quick Release Axle | Left/Right wheel
Synchronized Control | Regenerative Brake | Down Slope Speed Regulation | Certification |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 24"/22" | Puncture proof | QR only | Provided | Provided | Provided | EN12184
(Electrically powered wheelchairs, scooters
and their chargers – Requirements and test
methods) |
| 24" / 22" | Pneumatic | QR only | Provided | Provided | Provided | EN12184:2014
(Electrically powered wheelchairs, scooters
and their chargers - Requirements and test
methods) |
| 24" / 16" | Pneumatic | QR only | Provided | Same
| Provided | EN12184:2014
(Electrically powered wheelchairs, scooters and
their chargers - Requirements and test methods) |
| 16 inch model is for the user who needs the wheelchair
with recline or tilt function (See Pre Sale Information
Attachment-1 page 13-273).
16 inch model has the same platform with 24 inch model,
and it has the same safety function and reliability.
Toruque, speed, and other parameters have been tuned
for 16inch.
16 inch unit is proved to meet all regarding standards of
EN12184:2014, such as max speed, stopping distance,
static and dynamic stability, durability and so on.
The wheel size has no influence on the safety of the
powered propulsion. | | | | | | |
| Report Page:
18-76 TEST REPORT NO.20-C061
18-80 TEST REPORT NO.20-C063
Performance tests of wheel chair mechanical safety with
24/16 inch wheel passed. Test results conform to our
intended use. | | | | Same | Same | Same |
| | | | | Same
Report Page:
18-38 to 18-47 10 Propulsion and braking system
17-75 8.12 Brakes
Performance tests of braking system etc. passed.
Test results conform to our intended use. | Provided | |
| | | | | | Same
Report Page:
18-21 8.1.4 Maximum Downhill speed
18-26 8.1.8 Maximum speed
18-42 10.2.1(a) Requirement
17-72 5.3. Wheel Chair
Performance tests of downhill speed passed.
Test results conform to our intended use. | |