Power Wheelchair (JJW-6001)

K240563 · ZheJiang J&J Mobility Co., Ltd. · ITI · Oct 8, 2024 · Physical Medicine

Device Facts

• Record ID: K240563
• Device Name: Power Wheelchair (JJW-6001)
• Applicant: ZheJiang J&J Mobility Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended 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.

Device Story

Motor-driven transportation vehicle for indoor/outdoor mobility assistance; intended for disabled or elderly users. Input: user manipulation of joystick controller to dictate speed and direction. Operation: joystick signals processed by brushless dual-drive controller to power two 24VDC brushless DC motors; automatic electromagnetic brake system engages upon joystick release to stop movement. Output: physical displacement of wheelchair. Powered by rechargeable 24VDC Li-ion battery pack (16km range). Used in various environments by the patient; no specialized clinical operator required. Benefits: provides independent mobility for individuals with mobility impairments.

Clinical Evidence

No clinical data. Bench testing only, including ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic, obstacle climbing, power/control systems, labeling, EMC) and ISO 10993 (biocompatibility).

Technological Characteristics

Aluminum alloy frame; 4-wheel configuration (PU solid front tires, rubber pneumatic rear tires). Powered by 24VDC Li-ion battery; brushless DC motors (250W x 2). Joystick-controlled brushless dual-drive system. Electromagnetic braking. Off-board charger (100-240V AC). Complies with ISO 7176 series for performance/safety and ISO 10993 for biocompatibility.

Indications for Use

Indicated for disabled or elderly persons with mobility difficulties who are limited to a seated position.

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

• Power Wheelchair (K220747)

Submission Summary (Full Text)

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October 8, 2024 ZheJiang J&J Mobility Co., Ltd % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K240563

Trade/Device Name: Power Wheelchair (JJW-6001) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 20, 2024 Received: September 20, 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

# Tushar Bansal -S

for Heather Dean, PhD

Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K240563

Device Name Power Wheelchair (JJW-6001)

Indications for Use (Describe)

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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary K240563

#### A. Applicant:

ZheJiang J&J Mobility Co., Ltd Address: #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China Contact Person: Linda Cheng 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: Power Wheelchair Common Name: Powered wheelchair Model: JJW-6001

Regulatory Information Classification Name: Powered wheelchair Classification: Class II Product code: ITI

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Regulation Number: 890.3860 Review Panel: Physical Medicine

#### C. Predicate device:

510(k) Number: K220747 Device Name: Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices 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:

This Power Wheelchair, model: JJW-6001, 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, seatbelt, pedal, battery box and charger.

The device is powered by Li-ion Battery pack 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:

- > 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 A And Skin Sensitization
- > ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability >

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- 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 A electric wheelchairs and wheelchairs for determination of theoretical distance range
- ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall A 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
- 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 A 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 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support A devices Requirements and test method.
- > ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
- ISO 7176-22:2014 Wheelchairs-Part 22: Set-up procedures >
- ISO 7176-25:2022 Wheelchairs-Part 25: Lead-acid batteries and chargers for powered > Wheelchairs-Requirements and test methods
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment Part 1-2: General requirements > for basic safety and essential performance Collateral
- standard: Electromagnetic disturbances Requirements and tests >

#### G. Clinical Test Conclusion

No clinical study is included in this submission.

#### H. Comparison with predicate Device

#### Table 1 General Comparison

| Elements of<br>Comparison | Subject Device | Predicate Device (K220747) | Remark |
|---------------------------|---------------------------------|--------------------------------------------|--------|
| Manufacturer | ZheJiang J&J Mobility Co., Ltd. | Zhejiang Innuovo<br>Rehabilitation Devices | - |

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ZheJiang J&J Mobility Co., Ltd #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| | | Co.,Ltd | | Overall Dimension<br>(length*width*height) | 980*650*1050mm | 940*610*960mm | Analysis |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|----------|
| Common or Usual<br>name | Power Wheelchair | Power Wheelchair | Same | Folded Dimension<br>(length*width*height) | 810*650*390mm | 720*310*610mm | Analysis |
| Model(s) | JJW-6001 | N5515B | -- | Front wheel<br>size/type | 8" x 1.77"/PU Solid tire | 7" x 1.75"/PU Solid tire | Analysis |
| Indications for use | It is a motor driven, indoor and<br>outdoor transportation vehicle<br>with the intended use to provide<br>mobility to a disabled or elderly<br>person limited to a seated<br>position. | It is a motor driven, indoor<br>and outdoor transportation<br>vehicle with the intended use<br>to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | S.E. | Rear wheel size/type | 12" x 2.17" / rubber Pneumatic<br>tire | 8.5"x 2"/ PU Solid tire | Analysis |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E | Max speed forward | Up to 6 km/h (1.6 m/s),<br>adjustable | Up to 6 km/h (1.6 m/s),<br>adjustable | S.E |
| Number of wheels | 4,including two front wheels and<br>two rear Wheels | 4,including two front wheels<br>and two rear Wheels | S.E | Max Speed<br>backward | Less than 3 km/h (0.5 m/s) | Less than 3 km/h (0.5 m/s) | S.E |
| Function of wheels | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde.<br>Rear wheels: driving wheels to<br>control the speed and direction | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde.<br>Rear wheels: driving wheels<br>to control the speed and<br>direction | S.E | Max loading weight | 100kg | 136kg | Analysis |
| Movement control<br>method | By Joystick control | By Joystick control | S.E | Battery | Li-ion battery pack;<br>rechargeable, 24 VDC 12Ah | Li-ion battery pack;<br>rechargeable, 24 VDC 12Ah | S.E |
| Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | S.E | Maximum<br>distance<br>of travel on the fully<br>charged battery | 16km | 15 km | Analysis |
| Brake system | Automatic electromagnetic<br>brake system | Automatic electromagnetic<br>brake system | S.E | Motor | Brushless DC motor; 24VDC;<br>250W; 2pcs | Brushless DC motor;<br>24VDC; 250W; 2pcs | S.E |
| Braking distance | $\leq$ 1.5 m | $\leq$ 1.5 m | S.E | Electronic controller | Brushless dual-drive rocker<br>controller | Brushless dual-drive rocker<br>controller | S.E |
| Maximum safe<br>operational incline<br>degree | 10° | 9° | Analysis | Turning Radius | 815mm | 900 mm | Analysis |
| Armrest | PU | PU | S.E | Maximum obstacle<br>climbing | 25mm | 40 mm | Analysis |
| Battery charger | Off-board charger<br>Input: 100-240V, 50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | Off-board charger<br>Input: 100-240V, 50/60Hz,<br>1.5A,<br>Output: 24 Vdc, 2A; | S.E | | | | |
| Main frame material | Aluminum alloy | Carbon fiber material | Analysis | | | | |
| Back cushion | Polyester fiber | Polyester fabric | S.E | | | | |
| Seat cushion | Polyester fiber | rubber patch cloth and<br>Oxford fabric | Analysis | | | | |

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ZheJiang J&J Mobility Co., Ltd #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

#### Difference analysis:

The design and technological characteristics of the Power Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Main frame material, Seat cushion, Fold & Unfold dimension, Front & Rear wheels material & type, Max loading weight, Maximum distance of travel on the fully charged battery, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO7176 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 Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K220747).

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Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series.

| Item | Proposed Device | Predicate Devices | Results |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------|
| Biocompatibility | All user directly contacting<br>materials are compliance with<br>ISO10993-5, ISO10993-10<br>and ISO 10993-23<br>requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 & IEC 60601-2-1 | 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 2 Safety comparison

| Ite<br>m | Proposed Device | Predicate Devices | Res<br>ults |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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<br>meet 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<br>meet 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<br>meet 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 | The seating and wheel dimensions<br>has been determined after the testing | S.E. |
| | according to the ISO 7176-7 | according to the ISO 7176-7 | |
| 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<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 | 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<br>ISO 7176-15 | The test results shown that<br>information disclosure,<br>documentation and labelling of<br>device meet the requirements of<br>ISO 7176-15 | S.E. |
| ISO7176-<br>16/ ISO<br>16840-10 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 16840-10 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 7176-16 | S.E. |
| ISO 7176-<br>21 | The EMC performance results meet<br>the requirements of ISO 7176-21 | The EMC performance results meet<br>the requirements of ISO 7176-21 | S.E. |

#### Table 3 Safety comparison

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ZheJiang J&J Mobility Co., Ltd #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

#### I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k)

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submission, Power Wheelchair, Model: JJW-6001, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220747.