Power Wheelchair

K221026 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · ITI · Jul 1, 2022 · Physical Medicine

Device Facts

• Record ID: K221026
• Device Name: Power Wheelchair
• Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The W5905 Power Wheelchair 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. This product is suitabled people with mobility difficulties and elderly people.

Device Story

W5905 Power Wheelchair is a motor-driven, foldable mobility device for indoor/outdoor use; intended for disabled or elderly users. Input: user-operated joystick controls speed/direction. Operation: brushless DC motors drive rear wheels; automatic electromagnetic braking system engages upon joystick release. Output: physical mobility for the occupant. Used in clinics or home environments; operated by the patient. Benefits: provides independent mobility for individuals with walking limitations. Device includes main frame, seat, armrests, Li-ion battery, and controller. Healthcare providers use the device to facilitate patient transport; output is direct mechanical movement. No remote processing or cloud connectivity.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence was demonstrated through bench testing, including mechanical stability, braking effectiveness, energy consumption, electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993).

Technological Characteristics

Carbon fiber frame; brushless DC motors (250W x 2); 24V 12Ah Li-ion battery; electromagnetic braking; joystick controller. Dimensions: 930x577x930mm. Foldable design. Complies with ISO 7176 series (stability, braking, dimensions, fatigue, climatic, obstacle climbing, EMC). Sterilization not applicable.

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

• Y207 Electric Wheelchair (K202482)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

July 1, 2022

Zhejiang Innuovo Rehabilitation Devices Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221026

Trade/Device Name: W5905 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 6, 2022 Received: April 6, 2022

Dear Ivy Wang:

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

{1}------------------------------------------------

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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Heather Dean, PhD Assistant Director, Acute Injury Devices 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K221026

Device Name W5905 Power Wheelchair

Indications for Use (Describe)

The W5905 Power Wheelchair 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. This product is suitabled people with mobility difficulties and elderly people.

| 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)

# 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."

{3}------------------------------------------------

# 510(K) Summary

(As requirement by 21 CFR 807.92)

Date prepared: 21*, March, 2022

# A. Applicant:

Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China. Contact: Leo Zheng Title: General Manager Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: fda.sungo@@gmail.com

# B. Device:

Trade Name: W5905 Power Wheelchair Device Model: W5905

Regulatory Information K221026 Classification Name: Wheelchair, Powered Classification: Class II Product code: ITI Regulation Number: 21 CFR 890.3860 Review Panel: Physical Medicine C. Predicate device: K202482 Y207 Electric Wheelchair JIANGSU INTCO MEDICAL PRODUCTS CO., LTD

#### D. Device Description:

{4}------------------------------------------------

The subject Power Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling.

The subject Power Wheelchair is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.

The subject Power Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a seat cushion, a safety belt, two rear driving wheels and two front wheels. The electrical part is composed of two motors, two brakes, a li-ion battery, a controller and an off-board charger.

The device is powered by a Li-ion battery (24V 12Ah) with 15 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. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake.

#### E. Indication for Use

The W5905 Power Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.

| Attribute | Subject Device | Predicate Device | Discussion/Conclusion | Indications for Use | The W5905 Power<br>Wheelchair | The Y207 Electric<br>Wheelchair | Same |
|------------------------------|---------------------------------------------------------|-----------------------------------------------|-----------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Zhejiang Innuovo<br>Rehabilitation Devices Co.,<br>Ltd. | JIANGSU INTCO<br>MEDICAL PRODUCTS<br>CO., LTD | / | Intended user | Disabled or elderly person<br>limited to a seated position | Disabled people with<br>mobility difficulties and<br>elderly people | Same |
| Proprietary<br>name, model | Power Wheelchair, W5905 | Electric Wheelchair, Y207 | / | Use condition | Indoor and outdoor use | Indoor and outdoor use | Same |
| Device<br>classification | Class II | Class II | Same | Number of<br>wheels | 4, including two front<br>wheels and two rear wheels | 4, including two front<br>wheels and two rear<br>wheels | Same |
| Classification<br>regulation | 21 CFR 890.3860 | 21 CFR 890.3860 | Same | Function of<br>wheels | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde<br>Rear wheels: driving wheels<br>to control the speed and<br>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 | Same |
| Product code | ITI | ITI | Same | Frame design | The frame of the wheelchair<br>is type capable of front and<br>rear close. The main part of<br>the frame can be folded for<br>saving space and convenient<br>storage and transportation.<br>The main frame is made of<br>carbon fiber. | The frame of the wheelchair<br>is type capable of front and<br>rear close. The main part of<br>the frame can be folded for<br>saving space and<br>convenient storage and<br>transportation. The main<br>frame is made of<br>high-quality aluminum<br>material. | Analysis:<br>The two wheelchairs have<br>same frame design of front<br>and rear close. The<br>difference on the frame<br>material will not cause<br>safety and effectiveness<br>concerns. |
| Movement<br>control method | By joystick control | By joystick control | Same | | | | |
| Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | Same | | | | |
| Brake system | Automatic intelligent | Automatic intelligent | Same | | | | |

### F. Comparison of technological characteristics with the predicate device

{5}------------------------------------------------

{6}------------------------------------------------

| | electromagnetic<br>brake<br>system | electromagnetic<br>brake<br>system | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Braking<br>distance | ≤1.5m | ≤1.5m | Same |
| Battery | Li-ion battery; rechargeable,<br>24 VDC 12Ah | Li-ion battery pack;<br>rechargeable, 24 VDC<br>20Ah | <b>Analysis:</b><br>Difference of battery<br>capacity between the<br>proposed and predicate<br>devices may cause<br>difference on working<br>hours of the devices in<br>fully charged status, which<br>will not impact on the safe<br>and effectiveness of the<br>proposed device. |
| Maximum<br>distance<br>of<br>travel on the<br>fully charged<br>battery | 15km | 20km | <b>Analysis:</b><br>Difference of the<br>parameter is caused by the<br>rated capacity of battery,<br>which will not raise safe<br>and effectiveness<br>concerns. |
| Main frame<br>material | Carbon fiber | Aluminum alloy | <b>Analysis:</b><br>Difference of the materials<br>will not raise safe and<br>effectiveness concerns. |
| Seat cushion | Polyester fabric | Nylon braided belt | The biocompatibility tests<br>have been conducted to<br>verify the safety and<br>effectiveness of the<br>material. |
| Armrest | Carbon fiber | PU (polyurethane) | verify the safety and<br>effectiveness of the<br>material. |
| Overall<br>dimension<br>(L×W×H) | 930mm×577mm×930mm | 1100mm×700mm×980mm | <b>Analysis:</b><br>Difference on overall<br>dimension will only affect<br>the appearance of the<br>device but not affect the<br>safety and effectiveness of<br>the subject device. All |
| | | | safety and performance<br>have been validated with<br>the maximum rated weight<br>dummy or human occupant. |
| Folded<br>dimension<br>(L×W×H) | 325mm×577mm×790mm | 810mm×700mm×400mm | Analysis:<br>Difference on folded<br>dimension will not affect<br>safety and performance of<br>the subject device. |
| Ground<br>clearance | 70 mm | 160 mm | Analysis:<br>Difference on the<br>clearance will not not<br>affect safety and<br>performance of the subject<br>device. Performance tests<br>have been conducted<br>according to ISO 7176<br>series. |
| Front<br>wheel<br>size/type | 7"×2"/PU solid tire | 8"×2"/PU solid tire | Analysis:<br>Different sizes of front<br>wheel will not affect<br>safety and performance<br>of the subject device as all<br>related stability tests are<br>performed according to<br>standard ISO 7176 series. |
| Rear<br>wheel<br>size/type | 8"×2"/PU solid tire | 10"×3"/Pneumatic tire | Analysis:<br>Different sizes and<br>materials of rear wheel will<br>not affect the safety and<br>performance of the subject<br>device as all related<br>stability tests are performed<br>according to standard ISO<br>7176 series. |
| Max<br>speed<br>forward | 1.7 m/s (6 km/h) | 0-1.5m/s (5.4 km/h),<br>continuously adjustable | Analysis:<br>Slightly difference on the<br>parameter will not affect<br>the safety and<br>performance of the subject |
| Max<br>speed | 0.7m/s | 0.8m/s (2.88km/h) | performance of the subject |
| backward | | | device as all related<br>stability tests are<br>performed according to<br>standard ISO 7176 series. |
| Minimum<br>braking distance<br>from maximum<br>speed | Forward:0.8m | Forward: 1.0m | Analysis:<br>Shorter braking distance<br>in the subject device than<br>the predicate device, all<br>relevant tests are<br>performed according to<br>standard ISO 7176-3, no<br>safety and performance<br>will be affected. |
| Max loading<br>weight | 136 kg | 127kg (275 lbs) | Analysis:<br>Slightly difference on the<br>parameter will not affect<br>the safety and<br>performance of the subject<br>device as the related test<br>has been performed with a<br>dummy according to<br>standard ISO 7176 series. |
| Maximum safe<br>operational<br>incline degree | 9° | 8° | Analysis:<br>Slightly difference on the<br>parameter will not affect<br>the safety and<br>performance of the subject<br>device as the related test<br>has been performed<br>according to standard ISO<br>7176 series. |
| Battery charger | Off-board charger<br>Input:AC 100-240V, 50/60<br>Hz, 1.5A<br>Output: 24V dc, 2A<br>Charging time: 8-10 hours | Off-board charger<br>Input:100-240V, 50/60<br>Hz, 2.5A<br>Output:24V dc, 6A;<br>Charging time: 6 hours | Analysis:<br>Current difference will<br>impact charging time only,<br>which will not cause new<br>safety and effectiveness<br>concerns raised. |
| Motor | Brushless DC motor | Brushless motor; 24VDC; | Analysis: |
| | 250W x 24 VDC; 2 pcs | 200W; 2pcs | Slight difference on motor<br>power will not cause<br>different<br>performance.<br>Larger power will provide<br>more driving force, no<br>safety and effectiveness<br>concerns raised. |
| Electronic<br>controller | 35A<br>manufactured<br>by<br>Shanghai Micon Mechanical<br>& Electrical Co., Ltd. | newVSi ELECTRIC<br>WHEELCHAIR<br>CONTROL<br>SYSTEM, 50A<br>manufactured<br>by PG DRIVES<br>TECHNOLOGY LTD. | Analysis:<br>Difference on output<br>current will affect<br>charging time of the<br>subject device, which will<br>not cause safety and<br>effectiveness concerns. |
| Turning radius | 1200mm | 950mm | Analysis:<br>Larger turning radius will<br>bring more convenience for<br>the use environment. All<br>relevant tests have been<br>performed according to<br>standards ISO 7176 series,<br>the difference will not raise<br>any new safety and<br>effectiveness concerns. |
| Maximum<br>obstacle<br>climbing | 40mm | 50mm | Analysis:<br>Less distance in the<br>obstacle climbing will<br>not impact the safety<br>and effectiveness of the<br>subject device. |

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

# G. Summary of substantial equivalence discussion

The W5905 power wheelchair complied with the requirements of ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, IEC 62133-2:2017, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.

{10}------------------------------------------------

The instructions for use, design and technological characteristics of the subject Power Wheelchair are similar to the predicate device. Mainframes of the two devices are folded by way of front and rear close. The design principles of the controller and driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation has been carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Maximum obstacle climbing and maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-10:2008.

The biocompatibility of the predicate device and subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010. The flame retardant test of the seat cushion and armrest of both subject device and predicate device is carried out according to the ISO 7176-16 test. Therefore, both devices are assured to be under the same safety level.

In conclusion, the technological characteristics, features, specifications, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

# H. Summary of Non-clinical Tests

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 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity A
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
- > ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- A ISO 7176-2:2017, Wheelchairs - Part 2 Determination of dynamic stability of electric wheelchairs
- A ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- A ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- A ISO 7176-5: 2008 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 electric wheelchairs
- ISO 7176-7: 1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions A
- A ISO 7176-8: 2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- A ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically A powered wheelchairs

{11}------------------------------------------------

- ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies A
- A ISO 7176-13: 1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- A ISO 7176-14: 2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- A 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
- A ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters.
- ISO 7176-22: 2014 Wheelchairs Part 22: Set-up procedures A
- > ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchair
- Risk Analysis developed in accordance with ISO 14971:2019 A
- > Software evaluation
- A Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014

#### I. Biocompatibility of Patient-contacting material

Biocompatibility of patient-contacting material are evaluated in accordance with ISO 10993-1: 2018. Although there are risks related to cytotoxicity, sensitization and irritation, the risk level is very low as the patient-contacting parts of the power wheelchair are made from materials in common use for other consumer products with a similar nature of contact, in addition, the product quality is controlled and managed by design, manufacturing, quality control, safety instruction, or warning information, hence the biological safety of the power wheelchair is acceptable without further biocompatibility testing on some parts contacted with the user during operation procedure of the product.

#### J. Summary of Clinical Testing

No clinical or animal study is available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.

#### K. Conclusion

The differences between W5905 power wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device power wheelchair is substantially equivalent to the legally marketed predicate device.