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 Description

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.

AI/ML Overview

The provided text describes the W5905 Power Wheelchair's equivalence to a predicate device (Y207 Electric Wheelchair) for FDA 510(k) clearance, not the detailed acceptance criteria and study proving its performance in a clinical or AI context. The document focuses on performance requirements according to international standards (ISO and IEC) for wheelchairs.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a table format directly alongside "reported device performance" from a study. Instead, it refers to compliance with various ISO and IEC standards that define performance requirements for power wheelchairs. The "performance" described is the subject device meeting these standards.

Here's an attempt to extract relevant comparison points, which can be interpreted as the device meeting specific performance specifications relative to the predicate device and relevant standards:

Requirement/Characteristic (Proxy for Acceptance Criteria)	Predicate Device Performance	Subject Device Performance	Discussion/Conclusion from Document
Braking distance	≤1.5m	≤1.5m	Same
Maximum distance of travel on fully charged battery	20km	15km	Difference due to battery capacity, no safety/effectiveness impact.
Braking distance from maximum speed (Forward)	1.0m	0.8m	Shorter braking distance in subject device. All relevant tests performed according to ISO 7176-3, no safety/performance affected.
Max loading weight	127kg (275 lbs)	136 kg	Slight difference, related test performed with dummy according to ISO 7176 series.
Maximum safe operational incline degree	8°	9°	Slight difference, related test performed according to ISO 7176 series.
Maximum speed forward	0-1.5m/s (5.4 km/h)	1.7 m/s (6 km/h)	Slight difference, won't affect safety/performance; stability tests performed per ISO 7176 series.
Maximum speed backward	0.8m/s (2.88km/h)	0.7m/s	Slight difference, won't affect safety/performance; stability tests performed per ISO 7176 series.
Minimum obstacle climbing	50mm	40mm	Less distance in obstacle climbing, no safety/effectiveness impact.
Controller System Compliance	Meets ISO 7176-14:2008	Meets ISO 7176-14:2008	Same design principles, both meet the standard. Software validation conducted.
Brake System Compliance	Meets ISO 7176-3:2012	Meets ISO 7176-3:2012	Both meet the standard.
Biocompatibility	Meets ISO 10993-5:2009 & ISO 10993-10:2010	Meets ISO 10993-5:2009 & ISO 10993-10:2010	Both meet the requirements.
Flame Retardancy of Seat/Armrest	ISO 7176-16 test	ISO 7176-16 test	Both assured same safety level.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing performed on the device itself to comply with various ISO and IEC standards. These tests are typically performed on a sample of the manufactured device. However, the exact "sample size" (e.g., number of units tested) for each specific test is not explicitly mentioned in the provided text.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these engineering and performance standard tests. The tests are focused on the physical device's characteristics and its ability to meet documented engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The product is a power wheelchair, and the evaluation is based on engineering and performance standards (e.g., braking distance, stability, battery life), not on human interpretation or diagnosis. Therefore, "ground truth" established by medical experts is not relevant to this type of device clearance. The "ground truth" is the objective measurement against the specified standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. The evaluation here is based on objective, quantifiable engineering tests, not subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a power wheelchair, not an AI-powered diagnostic or assistive technology that involves human readers interpreting cases or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is not an algorithm or AI system. It's a physical medical device (a power wheelchair).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is defined by the objective, measurable criteria stipulated in the international standards (e.g., ISO 7176 series, IEC 60601-1-2) themselves. For instance, the ground truth for "braking distance" is the actual distance measured under specified conditions, compared against the maximum allowed distance by the standard. For "biocompatibility," the ground truth is whether the materials, when tested, meet the criteria for non-toxicity, non-irritation, and non-sensitization as defined by ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable. The device does not utilize a training set or AI.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K221026

Device Name W5905 Power Wheelchair

Indications for Use (Describe)

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

(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: +86 18358936043 Email: snail821@163.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 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:

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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 PowerWheelchair	The Y207 ElectricWheelchair	Same
Manufacturer	Zhejiang InnuovoRehabilitation Devices Co.,Ltd.	JIANGSU INTCOMEDICAL PRODUCTSCO., LTD	/	Intended user	Disabled or elderly personlimited to a seated position	Disabled people withmobility difficulties andelderly people	Same
Proprietaryname, model	Power Wheelchair, W5905	Electric Wheelchair, Y207	/	Use condition	Indoor and outdoor use	Indoor and outdoor use	Same
Deviceclassification	Class II	Class II	Same	Number ofwheels	4, including two frontwheels and two rear wheels	4, including two frontwheels and two rearwheels	Same
Classificationregulation	21 CFR 890.3860	21 CFR 890.3860	Same	Function ofwheels	Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirection	Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirection	Same
Product code	ITI	ITI	Same	Frame design	The frame of the wheelchairis type capable of front andrear close. The main part ofthe frame can be folded forsaving space and convenientstorage and transportation.The main frame is made ofcarbon fiber.	The frame of the wheelchairis type capable of front andrear close. The main part ofthe frame can be folded forsaving space andconvenient storage andtransportation. The mainframe is made ofhigh-quality aluminummaterial.	Analysis:The two wheelchairs havesame frame design of frontand rear close. Thedifference on the framematerial will not causesafety and effectivenessconcerns.
Movementcontrol method	By joystick control	By joystick control	Same
Driving system	Direct drive on the rearwheels	Direct drive on the rearwheels	Same
Brake system	Automatic intelligent	Automatic intelligent	Same

F. Comparison of technological characteristics with the predicate device

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	electromagneticbrakesystem	electromagneticbrakesystem
Brakingdistance	≤1.5m	≤1.5m	Same
Battery	Li-ion battery; rechargeable,24 VDC 12Ah	Li-ion battery pack;rechargeable, 24 VDC20Ah	Analysis:Difference of batterycapacity between theproposed and predicatedevices may causedifference on workinghours of the devices infully charged status, whichwill not impact on the safeand effectiveness of theproposed device.
Maximumdistanceoftravel on thefully chargedbattery	15km	20km	Analysis:Difference of theparameter is caused by therated capacity of battery,which will not raise safeand effectivenessconcerns.
Main framematerial	Carbon fiber	Aluminum alloy	Analysis:Difference of the materialswill not raise safe andeffectiveness concerns.
Seat cushion	Polyester fabric	Nylon braided belt	The biocompatibility testshave been conducted toverify the safety andeffectiveness of thematerial.
Armrest	Carbon fiber	PU (polyurethane)	verify the safety andeffectiveness of thematerial.
Overalldimension(L×W×H)	930mm×577mm×930mm	1100mm×700mm×980mm	Analysis:Difference on overalldimension will only affectthe appearance of thedevice but not affect thesafety and effectiveness ofthe subject device. All
			safety and performancehave been validated withthe maximum rated weightdummy or human occupant.
Foldeddimension(L×W×H)	325mm×577mm×790mm	810mm×700mm×400mm	Analysis:Difference on foldeddimension will not affectsafety and performance ofthe subject device.
Groundclearance	70 mm	160 mm	Analysis:Difference on theclearance will not notaffect safety andperformance of the subjectdevice. Performance testshave been conductedaccording to ISO 7176series.
Frontwheelsize/type	7"×2"/PU solid tire	8"×2"/PU solid tire	Analysis:Different sizes of frontwheel will not affectsafety and performanceof the subject device as allrelated stability tests areperformed according tostandard ISO 7176 series.
Rearwheelsize/type	8"×2"/PU solid tire	10"×3"/Pneumatic tire	Analysis:Different sizes andmaterials of rear wheel willnot affect the safety andperformance of the subjectdevice as all relatedstability tests are performedaccording to standard ISO7176 series.
Maxspeedforward	1.7 m/s (6 km/h)	0-1.5m/s (5.4 km/h),continuously adjustable	Analysis:Slightly difference on theparameter will not affectthe safety andperformance of the subject
Maxspeed	0.7m/s	0.8m/s (2.88km/h)	performance of the subject
backward			device as all relatedstability tests areperformed according tostandard ISO 7176 series.
Minimumbraking distancefrom maximumspeed	Forward:0.8m	Forward: 1.0m	Analysis:Shorter braking distancein the subject device thanthe predicate device, allrelevant tests areperformed according tostandard ISO 7176-3, nosafety and performancewill be affected.
Max loadingweight	136 kg	127kg (275 lbs)	Analysis:Slightly difference on theparameter will not affectthe safety andperformance of the subjectdevice as the related testhas been performed with adummy according tostandard ISO 7176 series.
Maximum safeoperationalincline degree	9°	8°	Analysis:Slightly difference on theparameter will not affectthe safety andperformance of the subjectdevice as the related testhas been performedaccording to standard ISO7176 series.
Battery charger	Off-board chargerInput:AC 100-240V, 50/60Hz, 1.5AOutput: 24V dc, 2ACharging time: 8-10 hours	Off-board chargerInput:100-240V, 50/60Hz, 2.5AOutput:24V dc, 6A;Charging time: 6 hours	Analysis:Current difference willimpact charging time only,which will not cause newsafety and effectivenessconcerns raised.
Motor	Brushless DC motor	Brushless motor; 24VDC;	Analysis:
	250W x 24 VDC; 2 pcs	200W; 2pcs	Slight difference on motorpower will not causedifferentperformance.Larger power will providemore driving force, nosafety and effectivenessconcerns raised.
Electroniccontroller	35AmanufacturedbyShanghai Micon Mechanical& Electrical Co., Ltd.	newVSi ELECTRICWHEELCHAIRCONTROLSYSTEM, 50Amanufacturedby PG DRIVESTECHNOLOGY LTD.	Analysis:Difference on outputcurrent will affectcharging time of thesubject device, which willnot cause safety andeffectiveness concerns.
Turning radius	1200mm	950mm	Analysis:Larger turning radius willbring more convenience forthe use environment. Allrelevant tests have beenperformed according tostandards ISO 7176 series,the difference will not raiseany new safety andeffectiveness concerns.
Maximumobstacleclimbing	40mm	50mm	Analysis:Less distance in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device.

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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.

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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

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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.

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).