The SUNTEC Mechanical Wheelchair, model ST-WL-1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, and the upholstery fabric meets the Requirements of Section E, Part I for Upholstery Fabrics of California Technical Bulletin CAL 117: 2000 standard for flame retardance.

AI/ML Overview

The document provided is a 510(k) premarket notification for a mechanical wheelchair, the SUNTEC Mechanical Wheelchair, model ST-WL-1000. For medical devices like this, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through performance testing against recognized national or international standards, and a comparison to a legally marketed predicate device.

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

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

The acceptance criteria are generally established by the performance standards (ISO standards in this case), and the device performance is reported implicitly by the statement that the device "completed the performance tests in accordance with ISO 7176 series standards" and "function safely and effectively" and "performs as well as the legally marketed device." The comparison table directly addresses the performance relative to the predicate by noting "Same" or explaining why differences do not affect safety or effectiveness.

Acceptance Criteria (ISO Standards) and Reported Device Performance (as summarized by the manufacturer):

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7176-1:1999 (Static Stability)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-3:2012 (Effectiveness of Brakes)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-5:2008 (Overall Dimensions, Mass, Maneuvering Space)	Overall Length: 41" / 1050 mm (Same as predicate: No change in safety or effectiveness). Overall Width: 25" / 640 mm (Same as predicate: No change in safety or effectiveness). Handgrip Height: 29" / 740 mm (19.5% lower; not a change in safety/effectiveness if attendant's height is not too large). Stowage Length: 35.4" / 900 mm (Shorter length, increased convenience; no safety/effectiveness change). Stowage Width: 14.5" / 370 mm (Larger width, cannot stack more stuff; no safety/effectiveness change). Stowage Height: 36.2" / 915 mm (Same, no safety/effectiveness change). Total Mass: 38.5 lb / 17.5 kg (2.7% lighter, easier to maneuver). Mass of Heaviest Part: 25.5 lb / 11.7 kg (Lighter, easier to maneuver). Ground Clearance: 2.3" / 58.4 mm (Same, no safety/effectiveness change). Required Width of Angled Corridor: 34.4" / 875 mm (3.8% less; no safety/effectiveness change). Required Doorway Entry Depth: 59" / 1500 mm (13.6% larger; may bring inconvenience, but "ALWAYS ASK FOR HELP"; no safety/effectiveness change). Required Corridor Width for Side Opening: 28.5" / 725 mm (23.6% narrower, easier movement; no safety/effectiveness change).
ISO 7176-7:1998 (Seating Dimensions) Definitions and Measuring Method	Seat Plane Angle: 4° (5.3% larger; no safety/effectiveness change). Effective Seat Depth: 16.9"/430 mm (16% less; may bring less free space, but no safety/effectiveness change). Seat Width: 17.3" - 18.1" / 440-460 mm (Larger, more comfortable; no safety/effectiveness change). Effective Seat Width: 17.3"- 17.5"/ 440 - 445 mm (Less effective; no safety/effectiveness change). Seat Surface Height Front Edge: 18.9"/480 mm (1.6% lower, negligible difference; no safety/effectiveness change). Backrest Angle: 10° (19% larger, more comfortable; passes static/dynamic stability tests; no safety/effectiveness change). Backrest Height: 16.9"/430 mm (2% less, negligible; no safety/effectiveness change). Backrest Width: 18.1"/460 mm (12% larger, more space; no safety/effectiveness change). Footrest-to-Seat: 16.5"/420 mm (15% longer, fits taller person; no safety/effectiveness change). Footrest Clearance: 6.7"/170 mm (14.8% higher, overcomes obstacles; no safety/effectiveness change). Footrest Length: 5.9"/150 mm (18.7% shorter, still holds foot; no safety/effectiveness change). Footrest-to-Leg Angle: 90° (4.8% smaller, negligible; no safety/effectiveness change). Leg-to-Seat-Surface Angle: 97° (5.8% larger, negligible; no safety/effectiveness change). Armrest Height: 10.2"/260 mm (7.4% larger; no safety/effectiveness change). Front-of-Armrest to Backrest: 11.4"/290 mm (18.9% less, limited space but no safety/effectiveness change). Armrest Length: Same as predicate (No safety/effectiveness change). Armrest Width: Same as predicate (No safety/effectiveness change). Armrest Angle: 4° (16.6% smaller, related to arm feeling, not safety/effectiveness). Distance Between Armrests: 18.1"/460 mm (0.64% shorter, no safety/effectiveness change). Front Location of Armrest Structure: 11"/280 mm (21% less, provides enough holding space; no safety/effectiveness change). Handrim Diameter: 19.8"/505 mm (7.6% smaller; not related to safety/effectiveness change). Propelling Wheel Diameter: 23.6"/600 mm (1.9% smaller; no safety/effectiveness change). Horizontal Location of Axle: 1.18"/ 30 mm (43.4% shorter; no safety/effectiveness change). Vertical Location of Axle: 7"/180 mm (78% larger; no safety/effectiveness change). Castor Wheel Diameter: 7.8"/200 mm (4.7% larger, more capability; no safety/effectiveness change).
ISO 7176-8:2014 (Static, Impact and Fatigue Strength)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-11:2012 (Test Dummies)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-13:1989 (Coefficient of Friction of Test Surfaces)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-15:1996 (Information Disclosure, Documentation, Labeling)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
ISO 7176-16:2012 (Resistance to Ignition of Upholstered Parts)	Passed (Meets California Technical Bulletin CAL 117: 2000 standard for flame retardance, which would be covered by this ISO standard, and stated as "same resistance-ignitability fabric" as predicate).
ISO 7176-22:2014 (Set-up Procedures)	Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively).
Other Differences: Weight Capacity: 220 lbs / 100 kg (Predicate: 250 lbs) Casters Tire Type: PVC solid material (Predicate: PU solid material) Weight of Chair: 38.5 lb / 17.5 kg (Predicate: 39.6 lb)Warranty: 3 years for chair side frames (Predicate: 5 years)	Weight Capacity: Lighter wheelchair is maneuvered more easily; no change in safety or effectiveness. Casters Tire Type: PVC endures longer than PU; no change in safety or effectiveness. Weight of Chair: 2.7% lighter, easier to maneuver. Warranty: Shorter guarantee period means user pays more, not related to safety or effectiveness.

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

The document describes performance testing against ISO standards for the device itself. These are typically engineering tests performed on a sample of the manufactured device. The document does not specify a "sample size" in terms of subject count or a specific number of devices tested for each standard. It only states that the "subject devices completed the performance tests." There is no mention of data provenance (e.g., country of origin, retrospective/prospective). This type of submission relies on engineering test reports rather than clinical trial 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 to a submission for a mechanical wheelchair based on performance standards. "Ground truth" in this context would be the objective measurements and outcomes of the engineering tests according to the ISO standards. There are no human "experts" establishing conventional ground truth as one might find in an imaging or diagnostic AI study. The "experts" would be the engineers and technicians performing the standardized tests.

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

Not applicable. This is an engineering performance test, not a subjective evaluation requiring an adjudication method. Test results are objective measurements against defined criteria within the 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

Not applicable. This device is a mechanical wheelchair and does not involve AI or human "readers" or multi-reader multi-case studies.

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

Not applicable. This device is a mechanical wheelchair and does not involve an algorithm.

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

The "ground truth" for this device's performance is established by the objective measurements and pass/fail criteria defined within the referenced ISO performance standards. For example, static stability is measured against a specific angle without tipping, and brake effectiveness is measured by the stopping distance.

8. The sample size for the training set

Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.

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

Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2016

Danyang Suntec Auto Parts Co., Ltd. Jen Ke-Min Official Correspondent Jiepai Industrial Zone, Jiepai, Danyang Zhenjiang, 212300 CHINA

Re: K152878

Trade/Device Name: SUNTEC Mechanical Wheelchair, Model ST-WL-1000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 8, 2015 Received: December 16, 2015

Dear Jen Ke-Min:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152878

Device Name

SUNTEC Mechanical Wheelchair, model ST-WL-1000

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the word "SUNTEC" in a blue, sans-serif font. The word is centered within a blue oval. The background is white.

DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com

SECTION D

510(k) Summary of Safety and Effectiveness

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Image /page/4/Picture/0 description: The image contains the word "SUNTEC" in large, bold, dark blue letters. The word is centered inside of a white oval with a dark blue border. The oval is oriented horizontally.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com

510(k) SUMMARY of Safety and Effectiveness

Submitter's Name: DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China

Date Summary Prepared:	January 24, 2016
Proprietary Name:	SUNTEC Mechanical Wheelchair, model ST-WL-1000
Common or Usual Name:	Mechanical Wheelchair
Classification Name:	Mechanical Wheelchair, Class I, 21 CFR 890.3850
Product Code:	IOR
Official Correspondent:	Dr. Jen, Ke-Min
	Email: ceirs.jen@msa.hinet.net
	TEL: +886-3-5208829
	FAX: +886-3-5209783
Predicate Device	Valentine International Ltd.
	Valentine Steel Wheelchair, model 1000 (K130017)

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

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Image /page/5/Picture/0 description: The image shows the word "SUNTEC" in a bold, dark blue font. The word is enclosed in a dark blue oval. The background of the image is white.

DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815

FAX:86-511-86380182 Email:dysuntec@hotmail.com

Description of the device:

Following are features for the ST-WL-1000

Foldable wheelchair frame, lift up backrest handles and strap into place.
Handy pocket for transporting lightweight items.
One button easy release wheels.

Due to the features of the body structure, the rear two wheels can always contact the surface, and the vehicle can be operated on the rough surface. But the following surfaces are recommended NOT to operate on:

Sand surface
. Wet or icy surface
. Road maintenance hole metal cover
Avoid going up multiple steps.
Avoid using escalators. Use the elevator.
. Too steep incline over 10 degrees.
. Turning diameter: 31" / 785 mm
Ground clearance: 2.3" /58.4 mm
Curb climbing ability: 0.8" / 20.3 mm

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Image /page/6/Picture/0 description: The image shows the word "SUNTEC" in bold, dark blue letters. The word is centered inside a white oval with a dark blue border. The oval is oriented horizontally and takes up most of the frame.

DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182

Email:dysuntec@hotmail.com

Performance Testing:

1. ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (FDA Recognition Number: 16-158 )
1. ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012. (FDA Recognition Number: 16-192)
1. ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008. (FDA Recognition Number: 16-163)
1. ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998. (FDA Recognition Number: NA)
1. ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 2014. (FDA Recognition Number: NA)
1. ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012. (FDA Recognition Number: 16-190)
1. ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989. (FDA Recognition Number: 16-25)
1. ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996. (FDA Recognition Number: 16-27)
1. ISO 7176-16 Wheelchairs Part 16 Requirements and test methods for resistance to ignition of upholstered parts, 2012. (FDA Recognition Number: 16-191)
1. ISO 7176-22 Wheelchairs Part 22 Set-up procedures, 2014 (FDA Recognition Number: NA)

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Image /page/7/Picture/0 description: The image shows the word "SUNTEC" in a blue, bold, serif font. The word is centered inside a blue oval. The background is white.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com

COMPARISON TABLE

Comparison items	Predicate device(K130017)	Subject device(K152878)	Pose any change in safety oreffectiveness, compared with thepredicate device?
BRAND NAME	Valentine	SUNTEC	There is no change in safety oreffectiveness.
MANUFACTURER	Valentine InternationalLtd.	DANYANG SUNTECAuto Parts Co., Ltd.	There is no change in safety oreffectiveness.
MODEL NO	Steel Wheelchair, model1000	Mechanical Wheelchair,model ST-WL-1000	There is no change in safety oreffectiveness.
510(k) No.	K130017	K152878	There is no change in safety oreffectiveness.
Similarities
INTENDED USE	The device is intendedfor medical purposes toprovide mobility topersons restricted to asitting position.	Same intended use	There is no change in safety oreffectiveness.
OPERATINGENVIRONMENTS	For Indoor / Outdoor use	Same operatingenvironments	There is no change in safety oreffectiveness.
TECHNOLOGICALCHARACTERISTICS	According to ISO7176-1/-3/-5/-7/-8/-11/-13/ -15/-16 seriesstandards	Same technologicalcharacteristics	There is no change in safety oreffectiveness.
Overall dimensionsLengthWidthHeight	42"25.2"36.2"	Same overalldimensions	There is no change in safety oreffectiveness.
Seat dimensionsLengthHeightWidth	18"20"18"	18"20"17.3" - 18.1"	There is no change in safety oreffectiveness.
FRAMECross braceBackrest heightReclining backrestSeat sling	YESUn-adjustablefixedPadded Nylon	Same frame	There is no change in safety oreffectiveness.
ARMREST			There is no change in safety or effectiveness.
Arm pad	Padded	Same armrest
Flip back	YES, detachable
Height-adjustable	Pre-installed armrests
HANGERS			There is no change in safety or effectiveness.
Swing-away	YES	Same hangers
Elevating leg rest	YES
Articulating leg rest	YES
Footplate style	Padded
Heel loop	No
Footrest angle	10~15°
ACCESSORIES			There is no change in safety or effectiveness.
Anti-tipper	YES	YES
Fold down push handle	YES	YES
Seat belt	Optional	Optional
REAR AXLE			There is no change in safety or effectiveness.
Offset axle	YES	Same rear axle
Quick-release axle	YES
REAR WHEEL			There is no change in safety or effectiveness.
Size	24" * 1"	Same size
Tire type	PU Solid Material	Same tire type
Wheel Lock	Pull-to-Lock	Same wheel lock	There is no change in safety or effectiveness.
Ground Clearance	2.3" / 58.4 mm	Same ground clearance	There is no change in safety or effectiveness.
Climbing Angle	10 degrees	Same climbing angle	There is no change in safety or effectiveness.
Curb climbing ability	0.8"/ 20 mm	Same curb climbing ability	There is no change in safety or effectiveness.
Minimum turning diameter	31" / 785 mm	Same turning diameter	There is no change in safety or effectiveness.
Differences
Weight Capacity	250 lbs. /113.4 kg	220 lbs. / 100 kg	The users will maneuver the wheelchairmore easily for a lighter wheelchair.
Casters			PVC material will endure for a longer
Size	8"*1"	Same size	period than PU material. There is nochange in safety or effectiveness.
Tire type	PU solid material	PVC solid material
Handrim Diameter/material	22" / Steel Composite	19.8" / Steel Composite	10% smaller in handrim diameter is notrelated for a change in safety oreffectiveness.
Weight of Chair	39.6 lb / 18 kg	38.5 lb / 17.5 kg	2.7% lighter in total mass will make theuser or attendant more easily maneuverthe wheelchair.
Warranty
12 months for the main parts (footrest, wheel lock, armrest, cross braces, backrest canes, front fork, fork stem house)	12 months for the main part (footrest, wheel locks, armrest, cross braces, backrest canes, front fork, fork stem house).	The 2 years less guarantee period for chair side frames will make the user pay more money and it is not to do with the change in safety or effectiveness.
The chair side frames are guaranteed 5 years from the date of purchase.	The chair side frames are guaranteed 3 years from the date of purchase.

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Image /page/8/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, serif font. The word is centered within a white oval with a thin, dark blue border. The background of the image is white.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182

Email:dysuntec@hotmail.com

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Image /page/9/Picture/0 description: The image shows the word "SUNTEC" in a blue, sans-serif font. The word is centered within a blue oval. The background is white.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182

Email:dysuntec@hotmail.com

ISO 7176-5:2008

Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space

Full overall length	41" / 1050 mm	Same overall length	There is no change in safety oreffectiveness.
Overall width	25" / 640 mm	Same overall width	There is no change in safety oreffectiveness.
Handgrip height	36" / 920 mm	29" / 740 mm	19.5% lower in handgrip height willcause some uncomforting to a tallerperson and she/he may bow their waistto hold the wheelchair.As long as the attendant's height is nottoo large, a normal person will not feeluncomfortable (or to bow his/her waist)to hold the handgrip. There is nochange in safety or effectiveness.
Stowage length	42" / 1066 mm	35.4" / 900 mm	Shorter stowage length means thedevice can fit the limited width space
Stowage width	11.4" / 290 mm	14.5" / 370mm	of the more vehicles, leading to more
Stowage height	36.2" / 915 nm	36.2" / 915 mm	convenience, and larger stowage widthmeans you cannot stack more stuff onthe wheelchair. There is nothing to dowith the safety and effectivenessconcerns.
Total mass	39.6 lb / 18 kg	38.5 lb / 17.5 kg	2.7% lighter in total mass will makethe user or attendant more easilymaneuver the wheelchair.
Mass of heaviest part	39.6 lb / 18 kg	25.5 lb / 11.7 kg	Lighter mass will make the user orattendant easier to maneuver thewheelchair.
Ground clearance	2.3" / 58.4 mm	Same ground clearance	There is no change in safety oreffectiveness.
Required width of angledcorridor	35.8" / 910 mm	34.4" / 875 mm	3.8% less in angled corridor width hasnothing to do with safety oreffectiveness.
Required doorway entrydepth	52" / 1320 mm	59" / 1500 mm	13.6% larger in depth may bring someinconvenience, but we haverecommended users to "ALWAYS ASKFOR HELP". There is no change insafety or effectiveness.
Required corridor widthfor side opening	37.4" / 950 mm	28.5" / 725 mm	23.6% narrower in required corridorwidth will let the user move moreeasily in the narrower space.
ISO 7176-7:1998
Wheelchairs - Part 7: Determination of seating dimensions - Definitions and measuring method
Seat plane angle	3.8°	4°	5.3 % larger in seat plane angle cannotpose any change in safety oreffectiveness.
Effective seat depth	20"/514 mm	16.9"/430 mm	16% less in effective seat depth maybring less free space for adjustment,but there is no change in safety oreffectiveness.
Seat width	16.5"/420 mm	17.3" - 18.1" /440-460 mm	Larger seat width lets users feel morecomfortable.There is no change in safety oreffectiveness.
Effective seat width	19.3" / 490 mm	17.3"- 17.5"/440 - 445 mm	Less effective seat width means not topose a change in safety oreffectiveness.
Seat surface height atfront edge	19.2"/488 mm	18.9"/480 mm	1.6% lower in seat surface height has anegligible difference and will not posea change in safety or effectiveness.
Backrest angle	8.4°	10°	19% larger in backrest angle can bringa more comfortable feeling to the userand there is no change in safety oreffectiveness since it passes static anddynamic stabilities tests.
Backrest height	17.2"/439 mm	16.9"/430 mm	2% less in backrest height is negligiblefor posing a change of safety oreffectiveness.
Backrest width	16.1"/410 mm	18.1"/460 mm	12% larger in backrest width will bringmore space for user to load the body.There is no change in safety oreffectiveness.
Footrest-to-seat	14.3"/365 mm	16.5"/420 mm	15% longer in footrest-to-seat willmake the wheelchair easily load a tallerperson. There is no change in safety oreffectiveness.
Footrest clearance	5.8"/148 mm	6.7"/170 mm	14.8% higher in footrest clearance willmake the wheelchair more easilyovercome an obstacle and there is nochange in safety or effectiveness.
Footrest length	7.2"/184 mm	5.9"/150 mm	18.7% shorter in footrest length willnot make a change in safety oreffectiveness since 150 mm in footrestlength can easily hold a foot of anormal person.
Footrest-to-leg angle	94.6°	90°	4.8% smaller in footrest-to-leg angle isnegligible to pose a change in safety oreffectiveness.
			effectiveness.
Leg-to-seat-surface angle	91.6°	97°	5.8% larger in leg-to-seat-surface angleis negligible to pose a change in safetyor effectiveness.
Armrest height	9.5"/242 mm	10.2"/260 mm	7.4% larger in armrest height will notpose a change in safety oreffectiveness.
Front-of-armrest tobackrest	14"/358 mm	11.4"/290 mm	18.9% less distance in Front-of-armrestto backrest will let the user feel limitedin space but will not pose a change insafety or effectiveness.
Armrest length	10.2"/260 mm	Same length	There is no change in safety oreffectiveness.
Armrest width	21.6"/550 mm	Same width	There is no change in safety oreffectiveness.
Armrest angle	4.8°	4°	16.6% smaller in armrest angle isrelated to the arm feeling, not related tothe safety or effectiveness.
Distance betweenarmrests	18.2"/463 mm	18.1"/460 mm	0.64% shorter in distance betweenarmrests does not pose a change insafety or effectiveness.
Front location of armreststructure	13.9"/355 mm	11"/280 mm	21% less in front location of armreststructure will not pose a change insafety or effectiveness since 280 mmcan provide an enough holding space.
Handrim diameter	21.4"/546 mm	19.8"/505 mm	7.6% smaller in Handrim diameter isnot related to a change in safety oreffectiveness.
Propelling wheeldiameter	24"/612 mm	23.6"/600 mm	1.9% smaller in propelling wheeldiameter has nothing to do with achange in safety or effectiveness.
Horizontal location ofaxle	2"/53 mm	1.18"/ 30 mm	43.4% shorter in Horizontal location ofaxle has nothing to do with the safetyor effectiveness.
Vertical location of axle	3.9"/101 mm	7"/180 mm	78% larger in Vertical displacement ofwheel axle has nothing to do with thesafety or effectiveness.
Castor wheel diameter	7.5"/191 mm	7.8"/200 mm	4.7% larger in castor wheel diametercan provide more capability to moveon the road, but it is not to pose achange in safety or effectiveness.

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Image /page/10/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, sans-serif font. The word is centered within a white oval shape that is outlined with a thin, dark blue border. The background of the image is white.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182

Email:dysuntec@hotmail.com

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Image /page/11/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, sans-serif font. The word is centered inside a white oval with a thin, dark blue border. The oval is oriented horizontally.

Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182

Email:dysuntec@hotmail.com

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Image /page/12/Picture/0 description: The image shows the word "SUNTEC" in a bold, dark blue font. The word is centered inside a white oval with a thin, dark blue border. The oval is oriented horizontally.

DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com

COMPARISON DISCUSSION

From the above comparison table, we know that the intended uses of the subject device and the predicate device are the same. Mainframes of two devices are foldable. Removable desk-length armrest and the swing-away detachable elevating footrest are the same. Besides, back upholstery material is the same resistance-ignitability fabric and also meets the requirements for flame retardant. The minor differences in the castor tire type (PU vs. PVC) and the weight of chair (39.6 lb vs. 38.5 lb) do not raise any safety and effectiveness concerns or changes. The tire sizes are indicated on the product durable label. Thus the same safety level for the two devices is assured. At last, the chair side frames are guaranteed for 5 years from the date of purchase for predicate device and 3 years for the subject device. The difference is related with the more cost paid by the user for the chair side frames and does not raise any safety and effectiveness concerns.

Despite of the differences above and shown in the ISO 7176-5: 2008 and ISO 7176-7:1998 comparison table, the subject devices completed the performance tests in accordance with ISO 7176 series standards. They function safely and effectively. There are no safety or effectiveness concerns.

CONCLUSIONS

From the comparison table, we know that the subject device is as safe and effective as, and functions in a manner equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate device.

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).