The Power Wheelchair (N5515B) 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 Description

This Power wheelchair 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, pedal, battery box and charger.

The device is powered by Li-ion Battery pack (24V 12Ah) with 15 Km (9.32 miles) 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, 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Power Wheelchair (N5515B). The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K113463, Power wheelchair, PL00I by SUZHOU KD Medical Appliance Co. Ltd.).

Based on the provided text, the device in question is a power wheelchair, a device that does not typically use AI or require complex clinical studies for its clearance. Therefore, many of the requested criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not applicable or not provided in the context of a medical device like a power wheelchair. The clearance relies heavily on engineering performance standards and bench testing.

Here's the information that can be extracted from the provided text:

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

The document does not explicitly present specific numerical acceptance criteria for each test alongside the reported device performance. Instead, it states that the device "complied with the requirements" of various ISO and IEC standards. The comparison table (Section VI) highlights attributes where the subject device differs from the predicate but doesn't quantify "reported performance" against a specific, numerical acceptance criterion for each different attribute.

However, the "Braking distance," "Maximum safe operational incline degree," "Maximum speed forward," "Max backward Speed," "Max loading weight," "Maximum distance of travel," "Turning Radius," and "Maximum obstacle climbing" are performance metrics with specific values for both the subject and predicate devices.

Let's synthesize a table based on the explicit performance values and the implicit acceptance of compliance with standards:

Acceptance Criteria (Implied by Predicate/Standard Compliance)	Reported Device Performance (Subject Device N5515B)	Discussion from Document
Braking distance $\leq$ 1.5 m (from predicate)	$\leq$ 1.5 m	Same
Maximum safe operational incline degree 9° (from predicate)	9°	Same
Max speed forward Up to 6 km/h (from predicate)	Up to 6 km/h (1.6 m/s), adjustable	Minor difference, lower speed more safety.
Max backward Speed 2.4 mph (3.84 km/h) (from predicate)	Less than 3 km/h (0.5 m/s)	Lower speed on max. backward speed will be more safety.
Max loading weight 114 kg (251 lbs) (from predicate)	136kg (≈300 lbs)	Difference on loading weight will not cause different performance. More loading weight provides more convenient and stable performance.
Maximum distance of travel 20 km (from predicate)	15 km	Shorter driving distance will not cause new safety and effectiveness concerns.
Turning Radius 31.5" (800 mm) (from predicate)	900 mm	Minor difference, caused by different size, will not raise new safety concerns.
Maximum obstacle climbing 1.2" (30 mm) (from predicate)	40 mm	Longer distance in the obstacle climbing will not impact safety/effectiveness.
Compliance with ISO 7176 series	Complied with relevant ISO 7176 standards.	(General statement of compliance)
Compliance with IEC 60601-1-2:2014	Complied with IEC 60601-1-2:2014.	(General statement of compliance)
Biocompatibility (ISO 10993 series)	Complied with ISO 10993-1, -5, -10.	(General statement of compliance)
Software Validation	Software validation performed.	Discussed as similar to predicate.

Regarding the study that proves the device meets the acceptance criteria:

The study is implicitly a non-clinical performance testing (bench testing) conducted by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. For bench testing of physical products like wheelchairs against ISO standards, typically a representative number of units (often a small sample, e.g., 1-3 devices) are tested to demonstrate compliance and consistency in manufacturing processes. The document does not provide a specific number of devices tested.
Data Provenance: The document states the tests were "provided to verify that the subject device met all design specifications." This indicates the testing was conducted by or for the manufacturer (Zhejiang Innuovo Rehabilitation Devices Co., Ltd.) to support their submission. The country of origin for the data is China, as the manufacturer is based there. The nature of the testing is prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate compliance.

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):

Not applicable. This device is a power wheelchair, and its performance is evaluated against engineering standards (ISO, IEC) through bench testing, not against medical expert ground truth like in diagnostic imaging. The "ground truth" here is the established pass/fail criteria within the specified engineering standards.

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

Not applicable. This concept is relevant for studies involving human interpretation (e.g., radiologists assessing medical images) where discrepancies need to be resolved. For bench testing against engineering standards, the results are typically objectively measured and compared against predefined thresholds in the standards.

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:

Not applicable. This type of study is relevant for AI-powered diagnostic or assistive devices involving human readers (e.g., physicians interpreting images). The Power Wheelchair is a physical mobility device that does not involve human "readers" or AI assistance in this context.

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

Not applicable. The device is a physical power wheelchair, not an algorithm. While it has an electronic controller and software, the "performance" is the mechanical and electrical function of the wheelchair itself, not an isolated algorithm. The software validation mentioned is part of the overall device performance verification.

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

The "ground truth" used is defined by the international engineering and safety standards (ISO 7176 series, IEC 60601-1-2, ISO 10993 series). The device's performance is measured against the specifications and test methods outlined in these standards. For biocompatibility, the ground truth is established by the tests themselves according to the ISO 10993 series.

8. The sample size for the training set:

Not applicable. There is no AI algorithm being "trained" in the typical sense for this device. The software validation is likely for embedded control software, which is traditionally developed, tested, and verified against functional requirements, not "trained" on a dataset.

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

Not applicable, as there is no training set for an AI algorithm in this context. The "ground truth" for embedded software validation would be its functional requirement specifications.

Summary

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May 12, 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: K220747

Trade/Device Name: Power Wheelchair (N5515B) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 14, 2022 Received: March 14, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220747

Device Name

Power Wheelchair (N5515B)

Indications for Use (Describe)

The Power Wheelchair (N5515B) is a motor driven, indoor wansportation 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

l. SUBMITTER

Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China

Name of contact person: Leo Zheng

Telephone: +86 18358936043

Fax: +86-579-89327232

Date prepared: 2022-05-05

II. Device

Device trade name: Power Wheelchair (N5515B)

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

III. Predicate device

K113463

Power wheelchair, PL00I

SUZHOU KD Medical Appliance Co. Ltd.

IV. Device description

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.

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V. Indication for use

The 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.

VI. Comparison of technological characteristics with the predicate device

Attribute	Subject device	Predicate device	Discussion/Conclusion
Manufacturer	Zhejiang Innuovo Rehabilitation Devices Co., Ltd.	SUZHOU KD Medical Appliance Co. Ltd.	/
Proprietary name,model	Power Wheelchair, N5515B	power wheelchair, PL00I	/
510(k) number	K220747	K113463	/
Device classificationname	Class II	Class II	Same
Classificationregulations	21 CFR 890.3860	21 CFR 890.3860	Same
Product code	ITI	ITI	Same
Similarities
Indication for use	The 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.	They are 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.	Same
Intended user	disabled people with mobility difficulties and elderly people	disabled or elderly person limited to a seated position	Same
Use condition	indoor and outdoor use	indoor and outdoor use	Same
Number of wheels	4, including two front wheels and two rear wheels	4, including two pivoting casters and two rear drive wheels	Same
Function of wheels	Front wheels: driven	two pivoting casters: driven	Same
Attribute	Subject device	Predicate device	Discussion/ Conclusion
	wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and direction	wheels suitable for rotation, acceleration, retrogradetwo rear drive wheels: driving wheels to control the speed and direction
Movement control method	By Joystick control	By Joystick control	Same
Driving system	Direct drive on the rear wheels	Direct drive on the rear wheels	Same
Brake system	Automatic electromagnetic brake system	Intelligent regenerative Electromagnetic brake	Same
Braking distance	$\leq1.5$ m	Forward: 1.5m (59") at max speed	Same
Maximum safe operational incline degree	9°	9°	Same
Armrest	PU	PU	Same
Battery charger	Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A;	Off-board, Automatic TypeInput: 110-220 V / 50-60 Hz,Output: 24 Vdc, 2A;	Same
Differences
Main frame material	Carbon fiber material	aluminum alloy	Different material used for frame, that such difference will not impact the safety and effectiveness of the subject device as the performance tests are conducted according to ISO 7176 series. The carbon fiber material is lighter and easy to carry.
back cushion	Polyester fabric	PU foam covered by nylon fabric cloth	different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as
Attribute	Subject device	Predicate device	Discussion/Conclusion
seat cushion	rubber patch cloth and Oxford fabric	PU foam covered by nylon fabric cloth	carried out according to ISO 10993 series. 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.
Overall Dimension (lengthwidthheight)	940610960mm	880570890mm	larger size is designed for bearing more loading weight.
Stowage Dimension (lengthwidthheight)	720310610mm	720570400mm	All safety and performance have been validated with the maximum rated weight dummy.
Front wheel size/type	7" x 1.75"/PU Solid tire	6" x 2" /PU Solid tire	Minor difference on dimension of driven wheel will not cause different performance.
Rear wheel size/type	8.5"x 2"/ PU Solid tire	8" x 2.4"/PU Solid tire	Minor difference on dimension of driving wheel will not cause different performance.
Max speed forward	Up to 6 km/h (1.6 m/s), adjustable	Up to 6 km/h (3.75 mph), variable	minor difference on max. forwarding speed will not cause different performance. lower speed will be more safety.
Max backward Speed	Less than 3 km/h (0.5 m/s)	2.4 mph (3.84 km/h)	lower speed on max. backward speed will be more safety.
Max loading weight	136kg (≈300 lbs)	114 kg (251 lbs)	Difference on loading weight will not cause different performance. more loading weight provide more convenient and stable performance
Attribute	Subject device	Predicate device	Discussion/Conclusion
Battery	li-ion battery pack; rechargeable, 24 VDC 12Ah	Li-ion, Rechargeable; 24 VDC 20Ah	for the transportation. the battery capacity will impact the travel distance, which will not cause new safety and effectiveness concerns raised.
Maximum distance of travel on the fully charged battery	15 km	20 km	Shorter driving distance will not cause new safety and effectiveness concerns raised.
Motor	Brushless DC motor; 24VDC; 250W; 2pcs	Brushless DC motor; 24 VDC; 180 W; 2 pcs	minor difference on motor power will not cause different performance. larger power will provide more driving force, no safety and effectiveness concerns raised.
Electronic controller	Brushless dual-drive rocker controller	Brushless dual-drive rocker controller	Similar controller is used, both the control system, including the joystick controller, the electromagnetic brakes and the user interface are similar. The joystick controls the directions and speed of movement, and when the joystick is released, the powered wheelchair will slow down to stop and the brakes will automatically re-engage. The controller also provides the battery status displaying and abnormal condition displaying. Both of the control systems are evaluated according to standard ISO 7176-14:2008 and
Attribute	Subject device	Predicate device	Discussion/Conclusion
			software validationrequirement and thereare no new safety andeffectiveness concernsdue to the difference.
Turning Radius	900 mm	31.5" (800 mm)	The minor difference inthe turning radius iscaused by different sizeof wheelchair and maycause a little bitinconvenience when itturns in a narrow spacewhile the minordifference will not raiseany new safety andeffectiveness concerns.
Maximum obstacleclimbing	40 mm	1.2" (30 mm)	Longer distance in theobstacle climbing will notimpact the safety andeffectiveness of thesubject device.

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VII. Summary of substantial equivalence discussion

The power wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, 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, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.

The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength, Yield Load, and Elongation tests. 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 is 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

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effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001, 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/backrest 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, materials, 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 devices do not raise new issues of safety or effectiveness.

VIII. Summary of non-clinical testing

A Performance testing-bench

The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

. Software validation
. ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
. ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
. ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
. ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
. ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering 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
. ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength

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. 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 powered wheelchairs
. ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
. ISO 7176-13:1989 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 scooters -- Requirements and test methods
. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
. ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
. ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
ISO 7176-22: 2014 Wheelchairs Part 22: Set-up procedures .
. ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.

A Biocompatibility of patient-contacting material

Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).

IX. Summary of clinical testing

No animal study and clinical studies are available for our device. Clinical testing was not required

to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.

X. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K113463.

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).