The electric wheelchair (Model: DH01108(2)) is a motor driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

Device Description

The proposed device, Electric Wheelchair , mainly powered by rechargeable battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, controller, battery pack, motor rear wheel, footplate, seat cushion, back cushion, handle.

The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.This wheelchair is suitable for the user who with weight less than 100kg.

The device is folding design. This foldable electric wheelchair has front frame, backrest frame,armrest. The wheelchair can be easily folded, when folding the wheelchair, turn over the armrest successively.

Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light.

Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward.

The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key.

Frame design: overall size: 905999cm, net weight: 22kg

The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.

The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on its performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria derived from clinical studies, expert-established ground truth, sample sizes for test and training sets, adjudication methods, or MRMC studies are not applicable or available in this document.

However, the document does detail non-clinical testing performed against established international standards to demonstrate safety and performance. I will present the information related to the closest equivalent of "acceptance criteria" and "device performance" available in the document, which are the relevant sections from the comparison to the predicate device and the summary of non-clinical testing.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" against which a device is tested with a singular "reported device performance." Instead, it performs a comparison to a predicate device and states that non-clinical tests were conducted according to various international standards. The "Verdict" column in the tables below indicates whether the subject device meets the same characteristics or if differences are deemed not to raise new safety or effectiveness concerns.

Element of Comparison / Test Standard	Acceptance Criteria (from Predicate or Standard) / Predicate Performance	Subject Device Performance	Verdict
General Characteristics
Manufacturer	JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.	Foshan Dahao Medical Technology Co.,Ltd.	--
Product Code	ITI	ITI	Same
Regulation No.	21 CFR 890.3860	21 CFR 890.3860	Same
Class	II	II	Same
Product name	Electric Wheelchair	Electric Wheelchair	Same
Intended Use	To provide mobility to a disabled or an elderly person limited to a seated position.	To provide mobility to a disabled or an elderly person limited to a seated position.	Same
Use environment	Indoor use	Indoor use	Same
Patient Population	Disabled or older adult limited to a sitting position	Disabled or older adult limited to a sitting position	Same
Product structure	Foldable armrests, backrest, seat cushion, foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, Li-ion batteries, off-board battery charger, control panel, electric motor controller.	Front frame, rear frame, backrest frame, two foldable armrests, two pivoting front wheel, controller, lithium-ion battery pack, two motor rear wheel, off-board battery charger, anti-roll wheel, footplate, seat cushion, back cushion, handle.	Same
Driving system	Direct drive on the rear wheels	Direct drive on the rear wheels	Same
Number of wheels	4	4	Same
Main frame material	Aluminium alloy	Aluminium alloy	Same
Max. loading	220lbs (100kg)	220lbs (100kg)	Same
Maximum safe operational incline	10 degrees	9°	Same (within acceptable range)
Speed control method	Joystick control method	Joystick control method	Same
Label and Labeling	Conforms to FDA Regulatory Requirements	Conforms to FDA Regulatory Requirements	Same
Level of Concern of the Software	Moderate	Moderate	Same
Performance Characteristics
Motor	DC24V* 180W*2pcs	DC 24V200W 2pcs	Minor differences in dimensions, will not impact safety.
Battery	DC 24V 20Ah Lithium-ion, 1 pcs	Lithium-ion 24V, 10AH, 1pcs	Minor differences in capacity, will not impact safety/effectiveness.
Battery charger Output	DC 24V, 6 Amp	DC 24V, 2.0Amp	Minor differences in output, will not impact safety/effectiveness.
Dimensions	38.1"x24.0"x37.0" (JRWD6010), 39.3"x23.6"x37.0" (JRWD6012)	90cm x59cm x99cm	Similar
Stowage dimensions (Lengthwidthheight)	44cm x40cm x46cm (JRWD6010) / 44cm x46cm x46cm (JRWD6012)	53cmx38cm x40cm	Minor difference, won't cause different performance as all performance tests are according to ISO 7176 series.
Weight, w/ Battery	58.4 lbs./26.5kg (JRWD6010), 58.2 lbs./26.4kg (JRWD6012)	48.5Ibs./22kg	Will not raise any new safety and effectiveness concerns.
Front wheel (inch)	8 (PU solid tire)	6 (PU solid tire)	Smaller sizes, will not raise new safety/effectiveness concerns.
Rear tire (inch)	10 (PU solid tire) (JRWD6010), 12 (Pneumatic tire) (JRWD6012)	8 (PU solid tire)	Will not raise any new safety/effectiveness concerns.
Cruising Range (km)	20 (JRWD6012)	10-25	Actual range varies; will not affect safety/effectiveness.
Obstacle climbing (mm)	50	25	Lower obstacle climbing, but will not affect safety/effectiveness.
Max. Speed (km/h)	6	5.4	Smaller max speed, but will not affect product function and safety.
Static stability forward	21.8°	≥6°	Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness.
Static stability rearward	19°	≥6°	Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness.
Static stability sideways	19.2°	≥6°	Both evaluated per ISO 7176-1:2014, differences won't impact safety/effectiveness.
Min. Turning radium	1820mm (JRWD6012)	900mm	Difference brings more convenience; will not raise new safety/effectiveness concerns.
Minimum braking distance	1m (JRWD6012)	≤1.6m (3°) (max safety slope braking)	Similar
Max Speed Forwards	3.75 mph (6 km/h)	5.4km/h	Both evaluated per ISO 7176-6:2018, differences won't impact safety/effectiveness.
Max. Speed Backward	2.80 mph (4.5 km/h)	5.4km/h	Both evaluated per ISO 7176-6:2018, differences won't impact safety/effectiveness.
Controller	PG Drives Technology Ltd., newVSI	GigaDevice Semiconductor Inc.	Different, but both control systems are similar in function and evaluated per ISO 7176-14:2008 and software validation; no new safety/effectiveness concerns.
Main materials (e.g., Frame)	Aluminium alloy	Aluminium alloy	Same
Materials contacting user	Armrest: PU; Backrest: oxford cloth; Seat: oxford cloth; Joystick knob: Santoprene 101-80; Joystick Gaiter: Silicone 3032 (50%) & 5031 (50%); Enclosure Moulding(s): ABS/PC Wonderloy PC-540; Keypad: Silicone keypad coatings TC-2407 & CH-6330	Armrest: PU; Backrest: PU; Seat: PU; Joystick controller: TPU(80%), Fire retardant(15%), Fertilize( 5%).	Different materials for some components, but biocompatibility evaluation (ISO 10993-1) was performed for the subject device; no new safety/effectiveness concerns.
Biocompatibility of materials contacting user	Comply with ISO 10993-1, FDA Cytotoxicity (ISO 10993-5:2009), Sensitization and Intracutaneous Reactivity (ISO 10993-10:2010)	Comply with ISO 10993-1, FDA Cytotoxicity (ISO 10993-5:2009), Sensitization and Irritation Reactivity (ISO 10993-10:2010)	Difference in irritation test (subject device only skin irritation); test qualified material in contact with patient; no new safety/effectiveness concerns.
Compliance with Standards
Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods	EN 12184:2014	EN 12184:2014, ISO 7176 series, IEC standards, ISO 10993 series	Complied
Static stability	ISO 7176-1: 2014	ISO 7176-1: 2014	Complied
Dynamic stability of electrically powered wheelchairs	ISO 7176-2: 2017	ISO 7176-2: 2017	Complied
Effectiveness of brakes	ISO 7176-3: 2012	ISO 7176-3: 2012	Complied
Energy consumption/theoretical distance range	ISO 7176-4: 2008	ISO 7176-4: 2008	Complied
Overall dimensions, mass and manoeuving space	ISO 7176-5: 2008	ISO 7176-5: 2018	Complied
Maximum speed, acceleration and deceleration	ISO 7176-6: 2018	ISO 7176-6: 2018	Complied
Measurement of seating and wheel dimensions	ISO 7176-7: 1998	ISO 7176-7: 1998	Complied
Static, impact and fatigue strengths	ISO 7176-8: 2014	ISO 7176-8: 2014	Complied
Climatic tests	ISO 7176-9: 2009	ISO 7176-9: 2009	Complied
Obstacle-climbing ability	ISO 7176-10: 2008	ISO 7176-10: 2008	Complied
Test dummies	ISO 7176-11: 2012	ISO 7176-11: 2012	Complied
Coefficient of friction of test surfaces	ISO 7176-13: 1989	ISO 7176-13: 1989	Complied
Power and control systems	ISO 7176-14: 2008	ISO 7176-14: 2008	Complied
Information disclosure, documentation and labeling	ISO 7176-15: 1996	ISO 7176-15: 1996	Complied
Resistance to ignition of postural support devices	ISO 7176-16: 2012	ISO 7176-16: 2012	Complied
Set-up procedures	ISO 7176-22:2014	ISO 7176-22:2014	Complied
Batteries and chargers for powered wheelchairs	ISO 7176-25: 2013	ISO 7176-25: 2013	Complied
Secondary cells and batteries (Safety requirements)	IEC 62133-2: 2017	IEC 62133-2: 2017	Complied
Electromagnetic compatibility (EMC)	ISO 7176-21: 2009	ISO 7176-21: 2009	Complied
Medical electrical equipment Part 1-2 (EMC)	IEC 60601-1-2:2015	IEC 60601-1-2:2015	Complied
Biological evaluation of medical devices (Risk management)	ISO 10993-1: 2018	ISO 10993-1: 2018	Complied
Cytotoxicity	ISO 10993-5:2009	ISO 10993-5:2009	Complied
Irritation and skin sensitization	ISO 10993-10:2010	ISO 10993-10:2010	Complied

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

The document describes non-clinical bench testing conducted according to ISO and IEC standards. These standards typically specify the number of units or samples required for each test. However, the exact sample sizes for each specific test (e.g., how many wheelchairs were subjected to fatigue strength testing) are not explicitly stated in this summary. The data provenance is "lab bench testing" (Paragraph 6, Page 5) in China (Company Address, Page 3). This is typically prospective testing of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical engineering and laboratory tests against recognized standards, not human-expert-driven ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not applicable as the document describes non-clinical engineering and laboratory tests based on objective measurements against standard requirements, not subjective assessment requiring adjudication.

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 information is not applicable. This is a submission for an Electric Wheelchair, not an AI software. The document explicitly states "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" (Paragraph 9, Page 11).

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

This information is not applicable. This is an Electric Wheelchair, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the requirements specified by various international consensus standards (EN 12184, ISO 7176 series, IEC 60601-1-2, IEC 62133-2, ISO 10993 series). The device's components and performance characteristics were tested against these pre-defined, objective criteria.

8. The sample size for the training set

This information is not applicable. This is a physical device, not an AI model requiring a training set.

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

This information is not applicable. (See point 8).

Summary

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July 5, 2022

Foshan Dahao Medical Technology Co.,Ltd % Iris Fung Regulation Manager Guangdong Jianda Medical Technology Co., Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong 510000 China

Re: K220827

Trade/Device Name: Electric Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 18, 2022 Received: March 22, 2022

Dear Iris Fung:

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) K220827

Device Name Electric Wheelchair

Indications for Use (Describe)

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.3860.

1. Submitter Information

Sponsor Company Name: Foshan Dahao Medical Technology Co.,Ltd. Address: Building 1, 2nd floor of building 2, 3rd floor of building 3、4、5、6、7, No.9 of Fanye Road,Leping town,Sanshui District,Foshan City,Guangdong Province,528137,China Phone: +86-13760674304 Contact Person (including title): BaoYi Xie (Regulation Manager) E-mail: 709111267@qq.com

Application Correspondent: Guangdong Jianda Medical Technology Co Ltd. Address:906 Room, Longxiang Garden, Tianhe district, Guangzhou, China Contact Person:Ms. Iris Fung Tile: Regulation Manager Tel:+86- 13211147965 Email:mdc-fs@foxmail.com; jianda-lee@foxmail.com

2. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Powered Wheelchair Trade Name: Electric Wheelchair Classification Name: Powered Wheelchair Review Panel: Physical Medicine Product Code: ITI Requlation Number: 21 CFR 890.3860 Regulation Class: Class II

3. Predicate Device Information

Sponsor: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Common Name: Powered Wheelchair Trade Name: Electric Wheelchair 510(k) number: K192739

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Review Panel: Physical Medicine Product Code: ITI Regulation Number: 21 CFR 890.3860 Regulation Class: Class II

4. Device Description

Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light.

Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward.

The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key.

Frame design: overall size: 905999cm, net weight: 22kg

The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.

The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.

5. Intended Use

The Electric Wheelchair (Model: DH01108 (2)) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

6. Test Summary of Non-clinical Testing

The Electrical Wheelchair has been evaluated the safety and performance by lab bench testing according to the following standards:

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. EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
. ISO 7176-1: 2014 Wheelchairs - Part 1: Determination of static stability
. ISO 7176-2: 2017 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered 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 overall dimensions, mass and manoeuving 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 strengths
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 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
. ISO 7176-25: 2013Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
. IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications-part 2: Lithium systems

EMC

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

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IEC 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for safety Collateral . standard: Electromagnetic compatibility - Requirements and tests

Biocompatibility

The parts in contact with the user include: Joystick controller, is made of 80% Thermoplastic poly urethane elastomer rubber(TPU), 15%Fire retardant and 5% Fertilizer. Armrest and seat cushion are made of 100% polyurethane (PU) . All contact materials have passed biological tests and are harmless to humans. Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including :

. 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
. ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

All contact materials have passed biological tests and are harmless to humans.

7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use,

functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	Foshan Dahao Medical TechnologyCo.,Ltd.	JERRY MEDICAL INSTRUMENT(SHANGHAI) CO., LTD.	--
Product Code	ITI	ITI	Same
Regulation No.	21 CFR 890.3860	21 CFR 890.3860	Same
Class	II	II	Same
Product name	Electric Wheelchair	Electric Wheelchair	Same
510 (k)Number	K220827	K192739	--
Models	DH01108 (2)	JRWD6010, JRWD6012	--
Intended Use	The Electric Wheelchair is a motor-driven, and indoor transportationvehicle with the intended use toprovide mobility to a disabled or anelderly person limited to a seated	The device is a motor-driven, andindoor transportation vehicle with theintended use to provide mobility to adisabled or an elderly person limitedto a seated position.	Same

Table1 General Comparison

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Elements of Comparison	Subject Device	Predicate Device	Verdict
	position.
Useenvironment	Indoor use	Indoor use	Same
PatientPopulation	The electric wheelchair is intended toprovide mobility to a person with adisability or an older adult limited toa sitting position	The electric wheelchair is intended toprovide mobility to a person with adisability or an older adult limited toa sitting position	Same
Productstructure	composed of front frame, rear frame,backrestframe, two foldablearmrests, two pivoting front wheel,controller, lithium-ion battery pack,two motor rear wheel,an off-boardbattery charger, anti-roll wheel,footplate, seat cushion, back cushion,handle ,a controller	Consists of two foldable armrests, abackrest, a seat cushion, a foldableframe, two rear driving wheels withhub motor/electromagnetic brakeassemblies, two pivoting casters, a Li-ion batteries, an off-board batterycharger, a control panel, and anelectric motor controller.	Same
Driving system	Direct drive on the rear wheels	Direct drive on the rear wheels	Same
Number ofwheels	4	4	Same
Main framematerial	Aluminium alloy	Aluminium alloy	Same
Motor	DC 24V200W 2pcs	DC24V* 180W*2pcs	Minor differencesin the dimensions
Battery	Lithium-ion 24V, 10AH,1pcs	DC 24V 20Ah Lithium-ion,1 pcs	will notimpact the safety
Battery charger	Input: 100-240VACoutput : DC 24V ,2.0Amp	High Power Technology Inc.HP0180WL2Input: 100-240 VACOutput: DC 24V, 6 Amp	andeffectivenessofthesubstantialequivalence.

Table2 Performance Comparison

Elements ofComparison	Subject Device	Predicate Device		Verdict
		JRWD6010	JRWD6012
Manufacturer	Foshan Dahao MedicalTechnology Co.,Ltd.	JERRY MEDICAL INSTRUMENT(SHANGHAI) CO., LTD.		--
Dimensions	90cm x59cm x99cm	38.1"x24.0"x37.0"	39.3"x23.6"x37.0"	Similar
Stowagedimensions(Lengthwidthheight)	53cmx38cm x40cm	44cm x40cmx46cm	44cm x46cmx46cm	Minor difference onStowage dimensionswill notcause differentperformance as allperformance tests areperformed according to
Elements ofComparison	Subject Device	Predicate Device		Verdict
		JRWD6010	JRWD6012
Weight,w/Battery	48.5Ibs./22kg	58.4 lbs./26.5kg	58.2 lbs./26.4kg	standard ISO7176 seriesThe difference willnot raise any new safetyand effectivenessconcerns and will notaffect the safety andeffectiveness of thesubject device.
Frame design	Foldable /The device consists of a foldableand non-rigid type of powerwheelchair base with rear driveand 2 casters in the front and 2anti-tippers in the rear.	Foldable /The device consists of a foldable andnon-rigid type of power wheelchairbase with rear drive and 2 casters in thefront and two anti-tippers in the rear.		Same
Foldingmechanism	A foldable seat frames(The backrest could be folded toseat)	A foldable seat frames(The backrest could be folded to seat)		Same
Front wheel(inch )	6(PU solid tire)	8(PU solid tire)		Smaller sizes ofwheels, The differencewill not raise any newsafety and effectivenessconcerns.
Rear tire(inch)	8(PU solid tire)	10(PU solid tire)	12(Pneumatic tire)	will not raise any newsafety and effectivenessconcerns.
CruisingRange(km)	10-25		20	Actual CruisingRange varies dependingon the rider's weight,environment and batteryusage, this will notaffect the safety andeffectiveness of thesubject device.
Obstacleclimbing(mm)	25	50		Subject Device has alower obstacle climbing,but this will not affectthe safety andeffectiveness of thesubject device.
Max. Speed(km/h)	5.4	6		Subject Device has asmaller Max. speed, butthis will not affect theuse of the productfunction and safety.
Static stabilityforward	≥6°	21.8°		Both of the devices areevaluated according tostandard ISO 7176-1:2014, so the differentstatic stability will notimpact the safety andeffectiveness.
Static stabilityrearward	≥6°	19°		standard ISO 7176-1:2014, so the differentstatic stability will notimpact the safety andeffectiveness.
Static stabilitysideways	≥6°	19.2°		static stability will notimpact the safety andeffectiveness.
Max. loading(kg)	220lbs(100kg)	220lbs (100kg)		Same
Maximum	9°	10 degrees		Same
Elements ofComparison	Subject Device	Predicate DeviceJRWD6010	Predicate DeviceJRWD6012	Verdict
safeoperationalincline
Min. Turningradium	900mm		1820mm	The difference in thetuming radius will bringmore convenience whenit turns.The differencewill not raise any newsafety and effectivenessconcerns.
Minimumbrakingdistance	max safety slope braking: ≤1.6m(3°)		1m	Similar
Max SpeedForwards	5.4km/h	3.75 mph (6 km/h)		Both of the devices areevaluated according to
Max. SpeedBackward	5.4km/h		2.80 mph (4.5 km/h)	standardISO 7176-6:2018, so the differentwill not impact thesafety and effectiveness
Controller	GigaDevice Semiconductor Inc.		PG Drives Technology Ltd., newVSI	Different Althoughdifferent controller isused, both the controlsystem, including thejoystick controller, theelectromagnetic brakesare similar. The joystickcontrols the directionsand speed of movement,and when the joystick isreleased, the poweredwheelchair will slowdown to stop and thebrakes willautomatically re-engage.The controller alsoprovides the batterystatus displaying andabnormal conditiondisplaying. Both of thecontrol systems areevaluated according tostandard ISO 7176-14:2008 and softwarevalidation requirementand there are no newsafety and effectivenessconcerns due to thedifference.
Speed controlmethod	Joystick control method		Joystick control method	Same
Elements ofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	Foshan Dahao MedicalTechnology Co.,Ltd.	JERRY MEDICAL INSTRUMENT(SHANGHAI) CO., LTD.	--
Main materials	Frame: Aluminiumalloy;Wheel, Armrest: PU;Backrest: PU	Frame: Aluminiumalloy;Wheel, Armrest: PU;Backrest: oxford cloth	The material for the
Materialscontacting user	Armrest: PU;Backrest:PUSeat: PUJoystick controller: TPU(80%),Fire retardant(15%),Fertilize( 5% ).	Armrest: PU;Backrest: oxford clothSeat: oxford clothnewVSi electric wheelchaircontroller:Joystick knob: Santoprene 101-80;Joystick Gaiter: Silicone 3032(50%) & 5031 (50%)Enclosure Moulding(s): ABS/PCWonderloy PC-540Keypad: Silicone keypad coatingsTC-2407 & CH-6330	main frame is the same.Biocompatibilityevaluationhasbeencarried out perISO10993-1.There are no new safetyandeffectivenessconcernsdue tothedifference.
Biocompatibilityof materialscontacting user	Comply with ISO 10993-1, FDACytotoxicity (ISO 10993-5:2009),Sensitization and IrritationReactivity (ISO 10993-10:2010)	Comply with ISO 10993-1, FDACytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010)	DifferenceintheIrritation test,the subjectdevice only made skincontact with the patient,so the skin irritation testwascarriedoutaccording to ISO10993-1, and the material incontact with the patientwasqualifiedbytest.There are no newsafety and effectivenessconcerns due tothedifference.
Label andLabeling	Conforms to FDA RegulatoryRequirements	Conforms to FDA RegulatoryRequirements	Same
Level ofConcern of theSoftware	Moderate	Moderate	Same

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Table3 Safety Comparison

8. Summary of substantial equivalence discussion

The DH01108 (2) Electric Wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2018, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-19:2008, 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.

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

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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, Max Speed and Static stability 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 7176-6: 2018, 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 subject device is carried out according to the ISO 7176-16 test. Therefore, the subject device meets the flame retardancy of FDA requirements.

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 devices do not raise new issues of safety or effectiveness. .

9. Summary of Clinical Test

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.

10. Conclusion

The differences between DH01108 (2) Electric 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 DH01108 (2) Electric Wheelchair is substantially equivalent to the legally marketed predicate device.

11. Summary Prepared Date

17 June 2022

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).