A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.

The device is mainly composed of painted frame, fireproof and breathable seat cushion, armrest, backrest, hand push tube, detachable leg, 8-inch front wheel, 24-inch rear wheel, brake group and anti-overturn device.

AI/ML Overview

The provided document describes the safety and performance testing for a manual wheelchair and not an AI or imaging device. Therefore, many of the requested fields are not applicable to this submission.

Here's the information that can be extracted and a note for non-applicable fields:

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

Description	Acceptance Criteria	Reported Device Performance
Static stability	Meets ISO 7176-1:2014	Meets ISO 7176-1:2014
Effectiveness of brakes	Meets ISO 7176-3:2012	Meets ISO 7176-3:2012
Dimensions, mass and maneuvering space	Meets ISO 7176-5:2008	Meets ISO 7176-5:2008
Seating and wheel dimensions	Meets ISO 7176-7:1998	Meets ISO 7176-7:1998
Static, impact, and fatigue strengths	Meets ISO 7176-8:2014	Meets ISO 7176-8:2014
Information disclosure, documentation and Labeling	Meets ISO 7176-15:1996	Meets ISO 7176-15:1996
Resistance to ignition	Meets ISO 7176-16:2012	Meets ISO 7176-16:2012
General requirements for wheelchairs	Meets ISO 7176-11:2012	Tests performed, met requirements
Determination of friction of test surface	Meets ISO 7176-13:1989	Tests performed, met requirements
Set-up procedures for wheelchairs	Meets ISO 7176-22:2014	Tests performed, met requirements
Biocompatibility (risk management, cytotoxicity, irritation/hypersensitivity)	Meets ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010	Tests performed, met requirements
Usability	User Manual understood and device operability	15 participants understood the User Manual and operated the device

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

Test set sample size: Not explicitly stated for each specific ISO test, but a "Usability Study" was conducted with 15 participants.
Data provenance: Not specified in the provided text. The manufacturing company is in China, which might suggest where the testing occurred, but it's not explicitly stated for the data provenance. It is a non-clinical/physical performance test, so "retrospective or prospective" is not directly applicable in the same way it would be for clinical data.

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 is not applicable as the document describes physical performance testing of a device against international standards, not expert-derived ground truth for an AI system. The "ground truth" here is the adherence to the published ISO standards and internal specifications.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human assessors, not for determining mechanical compliance with ISO 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

This is not applicable. The device is a manual wheelchair, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable. The device is a manual wheelchair, not an algorithm. Performance tests were conducted on the physical device itself.

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

The "ground truth" for the performance tests is adherence to international consensus standards (ISO 7176 series and ISO 10993 series) and the manufacturer's internal specifications.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" for a manual wheelchair.

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

This is not applicable. There is no AI model or "training set" for a manual wheelchair.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2022

Mobility Source Medical Technology Co., Ltd. % Shanfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, 62 Nanyun2 Road Huangpu District, Science City, Guangdong 510663 China

Re: K213790

Trade/Device Name: Manual wheelchair SYIV 100-LQXAL2482-407 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: December 6, 2021 Received: December 6, 2021

Dear Shanfeng Jiang:

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) K213790

Device Name Manual Wheelchair SYIV1OO-LQXAL2482-407

Indications for Use (Describe)

The device is intended for medical purposes to provide mobility to persons restricted to a sitting 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

Date of Summary Preparation: Nov,08, 2021

1. Submitter's Identifications

Submitter's Name: Mobility Source Medical Technology Co., Ltd.

1. Address: 160 Heheng Road, Yanghe Town, Gaoming District, Foshan City, Guangdong Province, China, 528513
  2 ) Contact Person: Evan Wong Contact Title: QA Manager Contact E-mail Address: evan@lqxmedical.com Telephone: +86- 757-88807188 Fax: +86-757-88809768 3 ) Manufacturer: Guangdong Shunde LQX Health Technology Inc. Address: Gujian Industrial Zone, Liangle Road Daliang Town, Shunde District Foshan City, Guangdong Province, China, 528000 Tel: +86-757-28091601 Fax: +86-757-28091602 Email: evan@lqxmedical.com

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, building A, 62 Nanyun2 Road, Science City, Huangpu District, Guangzhou China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address:jiang13620586569@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Device Classification Name: Wheelchair, Mechanical Product Name: Manual wheelchair SYIV100-LQXAL2482-407 Trade Name: Aluminum back folding wheelchair Model: SYIV100-LQXAL2482-407 Classification Panel: Physical Medicine Regulation Number: 21 CFR 890.3850 Product Code: IOR Device Classification: Class I

4. The Predicate Devices

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AST Model MA012 and MS019 Rehab Wheelchair K181795

5. Device Description

Operating principle

【Structure composition

【Main materials

Frame: high strength aluminum alloy 6061 - T6, external diameter of Ø 25.4 mm, wall thickness of 2.0 mm.

Armrest: high strength aluminum alloy 6061 - T6, external diameter of Ø 19 mm, wall thickness of 1.5 mm

Brake assembly: aluminum alloy

Seat and backrest: flame resistant fabrics

Tire: PU

6. Intended Use of Device

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

7. Summary of Substantial Equivalence

Table 1 Comparison to Predicate Device

	Proposed Device	Predicate device	Comparison
510k Number	K213790	K181795	------
Product Code	IOR	IOR	Same
Proprietary Name	ManualWheelchairSYIV100-LQXAL2482-407	AST Model MA012 andMS019 Rehab Wheelchair	------
Model	SYIV100-LQXAL2482-407	MA012 and MS019	------
Manufacturer	Guangdong Shunde LQXHealth Technology Inc.	Sichuan AST MedicalEquipment Co., Ltd.	------
Indications for Use	The device is intendedfor medical purposes toprovide mobility topersons restricted to a	The AST Model MA012 andMS019 Rehab Wheelchairsare to provide mobility topersons limited to a sitting	Same
	sitting position.	position.
Type of Use	Over-the-counter	Over-the-counter	Same
Basic Design	1. The wheelchairadopts aluminum alloytube frame andergonomic design, thesurface of the pianopaint treatment, toachieve high strength,high load bearing, lightweight, small volume,and at any time foldingstructure, do not take upspace, easy to carry;2. Seat depth andbackrest angle can beadjusted according tohuman comfort.3. Backrest height canbe adjusted.4. The armrest of thewheelchair can be liftedback, the height of thearmrest can be adjusted,the front and back canslide, the footplate canrotate, and the angle canbe adjusted.5. Front and rear wheelsadopt PU solid tire,fireproof and breathableseat cushion andbackrest.6. Backrest can be backfolding.7. The device can beequipped with drumbrake, easy for thecaregiver control anddown the steep slopecontrol flexibility andstability.	The AST Model MA012 andMS019 Rehab Wheelchair aremanual wheelchairs.They have adjustablearmrests, and multiple axleposition. The casters are6"/7"/8" PU wheels withheight adjustable forks andthe rear wheels are20"/22"/24"*1-3/8"polyurethane (MA012 andMS019).Aluminum frame with liquidcoated and folding backrestFlip-up and detachablearmrest PU padDetachable footrestFront casters PU tires andquick release rear wheel PUtiresNylon cushion	SimilarThe structureand materialsof mainframe of theproposeddevice andpredicatedevice aresame, onlyindividualmaterials aredifferent,such as backupholsteryand seatupholstery,etc.Thedifferencesdo not raisesafety andeffectivenessof theproposeddevice.

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	Materials		with aluminum alloybrake assembly.9. There is Equippedwith anti-overturndevice.Frame: high strengthaluminum alloy 6061 -T6, external diameter of$Ø$ 25.4 mm, wallthickness of 2.0 mm.Armrest: high strengthaluminum alloy 6061 -T6, external diameter of$Ø$ 19 mm, wallthickness of 1.5 mmBrake assembly:aluminum alloySeat and backrest: flameresistant fabricsTire: PU	AST Model MA012 RehabWheelchair: Aluminum framewith liquid coated and foldingbackrestFlip-up and detachablearmrest PU padDetachable footrestFront casters PU tires andquick release rear wheel PUtiresNylon cushion	SimilarThe Mainstructuralmaterials andwheelsmaterials aresame.Thedifferencesdo not raisesafety andeffectivenessof theproposeddevice.
	Components		The device is mainlycomposed of paintedframe, fireproof andbreathable seat cushion,armrest, backrest, handpush tube, detachableleg, 8-inch front wheel,24-inch rear wheel,brake group andanti-overturn device.	AST Model MA012 RehabWheelchair: Main frame,handle sleeve, backupholstery, seat upholstery,armrest pad, armrest, sidepanel, front casters, rearwheel, legrest, footplate,brake, front fork, cross-brace.	SameAlthough theexpressionsare different,the maincomponentsare same.
	Control Mode		Mechanical	Mechanical	Same
		Length	1070mm	Model MA012:1173mm( $\pm$ 1mm)	SimilarThe twophysical
Dimension		Width	625mm	Model MA012:645mm ( $\pm$ 1mm)	dimensionsare different.The

		Height	1035mm	Model MA012:892mm ( $\pm$ 1mm)	differencedoes notaffect theeffectivenessand safety

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Net weight	38.3 lbs/17.4kg	Model MA012:17.2kg/38lbs	SimilarTheproposeddeviceisheavier thanthe predicatedevice.
Weight capacity	300lbs/136kg	Model MA012:300lbs/136kg	Same
Seat width	446mm(17.6")	Model MA012:16"(406mm)18"(457mm)20"(508mm)	SimilarDifferentseat sizes donot raises thesafetyandeffectivenessofthedevice.
Seat height	518mm(20.4")	Model MA012:19.7"(500mm)
Seat depth	495mm(19.5")	Model MA012:16"-20"(406mm-508mm)
Frame type	foldable	foldable	Same
Cross-braceconfiguration	18"	14", 16", 18", 20" or 22"	SameCross-bracesizesofpredicatedeviceinclude withthatofproposeddevice.
Back style	Fixed	Model MS019: FixedModel MA012: Adjustable	Same
Anti-tippers	Optional	Optional	Same
Wheelconstruction	Quick release	Quick release	SameWheelconstructionof proposeddeviceissameaspredicatedevice modelSIVFH2A102.
Tires	Front:200mm (8")Rear: 600mm(24")	Front: 6",7",8"Rear: 20",22",24"	SameThetires
			sizes ofproposeddevice areincluded tothose ofpredicatedevice.
	Armrest	Flip back armrest	Model MA012: HeightAdjustable desk lengtharmrest, Flip backModel MS019: Fixed oradjustable height; desk or fulllength; removable	SimilarThe height ofarmest ofproposeddevice cannot beadjustable.
	Foot rest	Optional/ swing away	Optional/ swing away	Same
	Rear Axle Position	Single	Multiple	SimilarThe rear axleof proposeddevice hasonly onesize.
	Frame Material	high strength aluminumalloy	Model MA012: AluminumModel MS019: Steel	SameThe framematerial ofproposeddevice issame aspredicatedevice modelMA012.
	Safety Feature	Manual Wheel Lock	Manual Wheel Lock	Same
	Standard	ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16ISO7176-22ISO10993-1ISO10993-5	ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16ISO7176-22ISO10993-1ISO10993-5	Same
	ISO10993-10	ISO10993-10

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8. Substantial Equivalence discussion:

Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device.

The following table (Table 2) shows similarities and differences of the performance between our device and the predicate device. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for "Manual Wheelchair SYIV100-LQXAL2482-407" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.

Description	Proposed Device	Predicate device
Static stability	Meets ISO 7176-1:2014	Meets ISO 7176-1:2014
Effectiveness of brakes	Meets ISO 7176-3:2012	Meets ISO 7176-3:2012
Dimensions, mass andmaneuvering space	Meets ISO 7176-5:2008	Meets ISO 7176-5:2008
Seating and wheeldimensions	Meets ISO 7176-7:1998	Meets ISO 7176-7:1998
Static, impact, and fatiguestrengths	Meets ISO 7176-8:2014	Meets ISO 7176-8:2014
Information disclosure,documentation andLabeling	Meets ISO 7176-15:1996	Meets ISO 7176-15:1996
Resistance to ignition	Meets ISO 7176-16:2012	Meets ISO 7176-16:2012

Table 2: Comparison of Performance Testing

The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-22:2014.

A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Proposed Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

"Mechanical Wheelchair SIVFH2A102" meets performance requirements per ISO 7176-1:2014, ISO 7176-3: 2012, ISO 7176-5:2008, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-11:2012, 7176-13: 1989, ISO 7176-15: 1996, ISO 7176-16:2012 and ISO 7176-22:2014. It is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use.

A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is

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Substantially Equivalent (SE) to the predicate device which is US legally market device.

9. Non-Clinical Tests Performed:

following testing was performed on the "Mechanical Wheelchair The SYIV100-LQXAL2482-407" in accordance with the requirements of the design control regulations and established quality assurance procedures.

Safety and performance:

ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability

ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes

ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space

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 7176-11:2012 Wheelchairs - Part 11: Test dummies

ISO 7176-13:1989 Wheelchairs – Part 13: Determination of friction of test surface

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

Biocompatibility:

ISO 10993-1:2009 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 delayed-type hypersensitivity

10. Usability Study:

The 15 participants read the User Manual before initial use of the device. They can understand the questions and answer them. The 15 participants can operate the device referring to the User Manual.

Based on the verification & validation testing records provided, we concluded that the Manual Wheelchair, Model SYIV100-LQXAL2482-407 is considered to meet the usability requirement as defined in the verification & validation test report.

These non-clinical tests demonstrate that the labeling for the Manual Wheelchair, SYIV100-LQXAL2482-407, Model by Guangdong Shunde LQX Health Technology Inc. and bv US-Distributors is comprehensive, was well understood by a variety of "patients", and provided sufficient information for safe and proper use of the device.

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11. Conclusion:

Based on the comparison of the proposed device of SYIV100-LQXAL2482-407 is determined to be Substantially Equivalent (SE) to the predicate device of AST Model MA012 and MS019 Rehab Wheelchair, in respect of safety and effectiveness.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).