SUNTEC Mechanical Wheelchair, model ST-WL-1000

• K Number: K152878
• Device Name: SUNTEC Mechanical Wheelchair, model ST-WL-1000
• Manufacturer: DANYANG SUNTEC AUTO PARTS CO., LTD.
• Date Cleared: 2016-02-03 ( 126 days)
• Product Code: IOR
• Regulation Number: 890.3850

Intended Use

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

Device Description

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.

Predicate Devices

K130017

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance testing focus on mechanical aspects and standard wheelchair functionality, with no mention of AI or ML.

Therapeutic

No
Therapeutic devices are generally defined as those that treat or cure a disease or condition. This wheelchair is a mobility aid, providing support and enhancing a person's ability to move, but it does not directly treat or cure any medical condition.

Diagnostic

No
The device is a mechanical wheelchair providing mobility, not diagnosing medical conditions. The "Intended Use" clearly states its purpose is to "provide mobility to persons restricted to a sitting position."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Mechanical Wheelchair" with a base, wheels, and seat, and the performance studies are based on physical testing of the wheelchair's mechanical properties according to ISO standards.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "medical purposes to provide mobility to persons restricted to a sitting position." This describes a physical aid for mobility, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
• Device Description: The description details a mechanical wheelchair with components like a base, wheels, seat, and upholstery. This aligns with a mobility device, not an IVD.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing diagnostic information
  • Using reagents or assays

The information provided describes a standard medical device for mobility, specifically a wheelchair. The performance studies listed are also related to the physical characteristics and safety of a wheelchair, not diagnostic performance.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

IOR

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The subject device completed the performance tests in accordance with ISO 7176 series standards. These include:

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

Key results: They function safely and effectively. There are no safety or effectiveness concerns. 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.

Key Metrics

Not Found

Predicate Device(s)

K130017

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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 [phone] or [phone] 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 [phone] or [phone] 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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DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone] Email:[e-mail]

SECTION D

510(k) Summary of Safety and Effectiveness

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Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone] Email:[e-mail]

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: [e-mail]
	TEL: [phone]
	FAX: [phone]
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: [phone]

FAX:[phone] Email:[e-mail]

Description of the device:

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.

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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DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone]

Email:[e-mail]

Performance Testing:

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

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Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone] Email:[e-mail]

COMPARISON TABLE

| Comparison items | Predicate device
(K130017) | Subject device
(K152878) | Pose any change in safety or
effectiveness, compared with the
predicate device? |
|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| BRAND NAME | Valentine | SUNTEC | There is no change in safety or
effectiveness. |
| MANUFACTURER | Valentine International
Ltd. | DANYANG SUNTEC
Auto Parts Co., Ltd. | There is no change in safety or
effectiveness. |
| MODEL NO | Steel Wheelchair, model
1000 | Mechanical Wheelchair,
model ST-WL-1000 | There is no change in safety or
effectiveness. |
| 510(k) No. | K130017 | K152878 | There is no change in safety or
effectiveness. |
| Similarities | | | |
| INTENDED USE | The device is intended
for medical purposes to
provide mobility to
persons restricted to a
sitting position. | Same intended use | There is no change in safety or
effectiveness. |
| OPERATING
ENVIRONMENTS | For Indoor / Outdoor use | Same operating
environments | There is no change in safety or
effectiveness. |
| TECHNOLOGICAL
CHARACTERISTICS | According to ISO
7176-1/-3/-5/-7/-8/-11/-1
3/ -15/-16 series
standards | Same technological
characteristics | There is no change in safety or
effectiveness. |
| Overall dimensions
Length
Width
Height | 42"
25.2"
36.2" | Same overall
dimensions | There is no change in safety or
effectiveness. |
| Seat dimensions
Length
Height
Width | 18"
20"
18" | 18"
20"
17.3" - 18.1" | There is no change in safety or
effectiveness. |
| FRAME
Cross brace
Backrest height
Reclining backrest
Seat sling | YES
Un-adjustable
fixed
Padded Nylon | Same frame | There is no change in safety or
effectiveness. |
| 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 wheelchair
more easily for a lighter wheelchair. |
| Casters | | | PVC material will endure for a longer |
| Size | 8"*1" | Same size | period than PU material. There is no
change 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 not
related for a change in safety or
effectiveness. |
| Weight of Chair | 39.6 lb / 18 kg | 38.5 lb / 17.5 kg | 2.7% lighter in total mass will make the
user or attendant more easily maneuver
the 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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Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone]

Email:[e-mail]

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Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone]

Email:[e-mail]

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 or
effectiveness. |
|----------------------------------------------------------------------------------------------|-----------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overall width | 25" / 640 mm | Same overall width | There is no change in safety or
effectiveness. |
| Handgrip height | 36" / 920 mm | 29" / 740 mm | 19.5% lower in handgrip height will
cause some uncomforting to a taller
person and she/he may bow their waist
to hold the wheelchair.
As long as the attendant's height is not
too large, a normal person will not feel
uncomfortable (or to bow his/her waist)
to hold the handgrip. There is no
change in safety or effectiveness. |
| Stowage length | 42" / 1066 mm | 35.4" / 900 mm | Shorter stowage length means the
device 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 width
means you cannot stack more stuff on
the wheelchair. There is nothing to do
with the safety and effectiveness
concerns. |
| Total mass | 39.6 lb / 18 kg | 38.5 lb / 17.5 kg | 2.7% lighter in total mass will make
the user or attendant more easily
maneuver the wheelchair. |
| Mass of heaviest part | 39.6 lb / 18 kg | 25.5 lb / 11.7 kg | Lighter mass will make the user or
attendant easier to maneuver the
wheelchair. |
| Ground clearance | 2.3" / 58.4 mm | Same ground clearance | There is no change in safety or
effectiveness. |
| Required width of angled
corridor | 35.8" / 910 mm | 34.4" / 875 mm | 3.8% less in angled corridor width has
nothing to do with safety or
effectiveness. |
| Required doorway entry
depth | 52" / 1320 mm | 59" / 1500 mm | 13.6% larger in depth may bring some
inconvenience, but we have
recommended users to "ALWAYS ASK
FOR HELP". There is no change in
safety or effectiveness. |
| Required corridor width
for side opening | 37.4" / 950 mm | 28.5" / 725 mm | 23.6% narrower in required corridor
width will let the user move more
easily 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 cannot
pose any change in safety or
effectiveness. |
| Effective seat depth | 20"/514 mm | 16.9"/430 mm | 16% less in effective seat depth may
bring less free space for adjustment,
but there is no change in safety or
effectiveness. |
| Seat width | 16.5"/420 mm | 17.3" - 18.1" /
440-460 mm | Larger seat width lets users feel more
comfortable.
There is no change in safety or
effectiveness. |
| Effective seat width | 19.3" / 490 mm | 17.3"- 17.5"/
440 - 445 mm | Less effective seat width means not to
pose a change in safety or
effectiveness. |
| Seat surface height at
front edge | 19.2"/488 mm | 18.9"/480 mm | 1.6% lower in seat surface height has a
negligible difference and will not pose
a change in safety or effectiveness. |
| Backrest angle | 8.4° | 10° | 19% larger in backrest angle can bring
a more comfortable feeling to the user
and there is no change in safety or
effectiveness since it passes static and
dynamic stabilities tests. |
| Backrest height | 17.2"/439 mm | 16.9"/430 mm | 2% less in backrest height is negligible
for posing a change of safety or
effectiveness. |
| Backrest width | 16.1"/410 mm | 18.1"/460 mm | 12% larger in backrest width will bring
more space for user to load the body.
There is no change in safety or
effectiveness. |
| Footrest-to-seat | 14.3"/365 mm | 16.5"/420 mm | 15% longer in footrest-to-seat will
make the wheelchair easily load a taller
person. There is no change in safety or
effectiveness. |
| Footrest clearance | 5.8"/148 mm | 6.7"/170 mm | 14.8% higher in footrest clearance will
make the wheelchair more easily
overcome an obstacle and there is no
change in safety or effectiveness. |
| Footrest length | 7.2"/184 mm | 5.9"/150 mm | 18.7% shorter in footrest length will
not make a change in safety or
effectiveness since 150 mm in footrest
length can easily hold a foot of a
normal person. |
| Footrest-to-leg angle | 94.6° | 90° | 4.8% smaller in footrest-to-leg angle is
negligible to pose a change in safety or
effectiveness. |
| | | | effectiveness. |
| Leg-to-seat-surface angle | 91.6° | 97° | 5.8% larger in leg-to-seat-surface angle
is negligible to pose a change in safety
or effectiveness. |
| Armrest height | 9.5"/242 mm | 10.2"/260 mm | 7.4% larger in armrest height will not
pose a change in safety or
effectiveness. |
| Front-of-armrest to
backrest | 14"/358 mm | 11.4"/290 mm | 18.9% less distance in Front-of-armrest
to backrest will let the user feel limited
in space but will not pose a change in
safety or effectiveness. |
| Armrest length | 10.2"/260 mm | Same length | There is no change in safety or
effectiveness. |
| Armrest width | 21.6"/550 mm | Same width | There is no change in safety or
effectiveness. |
| Armrest angle | 4.8° | 4° | 16.6% smaller in armrest angle is
related to the arm feeling, not related to
the safety or effectiveness. |
| Distance between
armrests | 18.2"/463 mm | 18.1"/460 mm | 0.64% shorter in distance between
armrests does not pose a change in
safety or effectiveness. |
| Front location of armrest
structure | 13.9"/355 mm | 11"/280 mm | 21% less in front location of armrest
structure will not pose a change in
safety or effectiveness since 280 mm
can provide an enough holding space. |
| Handrim diameter | 21.4"/546 mm | 19.8"/505 mm | 7.6% smaller in Handrim diameter is
not related to a change in safety or
effectiveness. |
| Propelling wheel
diameter | 24"/612 mm | 23.6"/600 mm | 1.9% smaller in propelling wheel
diameter has nothing to do with a
change in safety or effectiveness. |
| Horizontal location of
axle | 2"/53 mm | 1.18"/ 30 mm | 43.4% shorter in Horizontal location of
axle has nothing to do with the safety
or effectiveness. |
| Vertical location of axle | 3.9"/101 mm | 7"/180 mm | 78% larger in Vertical displacement of
wheel axle has nothing to do with the
safety or effectiveness. |
| Castor wheel diameter | 7.5"/191 mm | 7.8"/200 mm | 4.7% larger in castor wheel diameter
can provide more capability to move
on the road, but it is not to pose a
change in safety or effectiveness. |

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Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: [phone] FAX:[phone]

Email:[e-mail]

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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: [phone] FAX:[phone]

Email:[e-mail]

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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: [phone] FAX:[phone] Email:[e-mail]

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.