Manual Wheelchair W54

• K Number: K180309
• Device Name: Manual Wheelchair W54
• Manufacturer: Jiangsu Jumao Medical Equipment Co., Ltd.
• Date Cleared: 2019-05-03 ( 455 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. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

Device Description

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. Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black. The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork. Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)

Predicate Devices

K170517, K151797

Reference Devices

K170517,K151797

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a purely mechanical wheelchair with no mention of AI/ML components or capabilities.

Therapeutic

No.
Explanation: A therapeutic device is used for the treatment or prevention of disease. This device, a mechanical wheelchair, provides mobility but does not treat or prevent a medical condition.

Diagnostic

No

The device description indicates it is a mechanical wheelchair, which is used for mobility, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a mechanical wheelchair with physical components made of steel, plastics, and fabrics. It does not mention any software as a primary or standalone component.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
• Device Description and Intended Use: The description and intended use of this device clearly state that it is a mechanical wheelchair designed to provide mobility to individuals who are restricted to a sitting position. It is a physical aid for movement, not a tool for analyzing biological samples.
• Lack of IVD Characteristics: The provided information does not mention any components, processes, or intended uses related to the analysis of biological specimens. There is no mention of reagents, assays, or any form of laboratory testing.

Therefore, based on the provided information, this device is a mobility aid and does not fit the definition of an In Vitro Diagnostic device.

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. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

Product codes

IOR

Device Description

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.

Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black.

The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork.

Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical tests.
Sample Size: Not specified for individual tests.
Key Results:

• "Mechanical Wheelchair W54" 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.
• Biocompatibility tests performed according to ISO 10993-1:2009/C1:2010, ISO 10993-5:2009, and ISO 10993-10:2010 for In Vitro Cytotoxicity Test, Skin Sensitization Test and Skin Irritation Test.
• Usability study with 15 participants: Participants could understand the user manual and operate the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170517, K151797

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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.

May 3, 2019

Jiangsu Jumao Medical Equipment Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong, 511660 CN

Re: K180309

Trade/Device Name: Manual Wheelchair W54 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 16, 2019 Received: April 16, 2019

Dear Jinghua Zhou:

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Carlos Peña. PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180309

Device Name Manual Wheelchair W54

Indications for Use (Describe)

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K180309 - 510(k) Summary

Revised Date of Summary: May 2, 2019 Date of Summary Preparation: August 1, 2018

1. Submitter's Identifications

Submitter's Name: Jiangsu Jumao Medical Equipment Co., Ltd. Address: No.36 Danyan road, Danyang City, Jiangsu, China, 212300 Contact Person: Qian Gao Contact Title: QA Manager Contact E-mail Address: [e-mail] Telephone: [phone] Fax: [phone]

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou(@126.com Telephone: [phone] Fax: [phone]

3. Name of the Device

Device Classification Name: Wheelchair, Mechanical Product Name: Mechanical Wheelchair Trade Name: Manual Wheelchair W54 Model: W54 Classification Panel: Physical Medicine Product Code: IOR Device Classification: Class I

4. The Predicate Devices

Primary Predicate: K170517 Merits Model R106/R136 Rehab Wheelchair Secondary Predicate: K151797 Nuocande Plastic Manual Wheelchair Model NKD L07

5. Device Description

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

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walking is difficult or impossible due to illness, injury, or disability.

Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black.

The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork.

Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)

The specification table is as below:

Type	W54
Occupant mass group	III
Control mode	Mechanical
Physical dimension	1160mm × 610mm × 890mm (depth × width × height)
Seat dimension	470mm × 425mm × 488mm (depth × width × height)
Stowage width	290mm
Handgrip height	870mm
Total mass	19.7kg
Weight capacity	300lb(136kg)
Required width of angled corridor	1000mm
Required doorway entry depth	1270mm
Required corridor width for side opening	1170mm
Armrest	Non flip back/Non height adjustable
Rear axle	Offset axle, Quick release axle
Real wheel	610mm(24inch)
Casters	190mm(8inch)
Wheel Lock	Pull to Lock
Color	Black

SPECIFICATIONS

Note: Physical dimension is the dimension when the device is equipped with the ordinary hanging leg (without leg supports and/or foot supports), and the Overall length with legrest is 1270mm.

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Information disclosure in manufacturer's specification sheets

Manufacturer: Jiangsu Jumao Medical Equipment Co., Ltd.

Address: No.36 Danyan road, Danyang City, Jiangsu, China, 212300

Model: W54

Maximum occupant mass: 300 lbs/136kg

Disclosure information (ISO)
Standard
reference		Min.	Max.	Standard
reference		Min.	Max.
ISO 7176-5	Overall length
with legrest		1270mm	ISO 7176-7
ISO7176-22	Seat plane
angle		6.2°
ISO 7176-5	Overall width		610mm	ISO 7176-7
ISO7176-22	Effective seat
depth		470mm
ISO 7176-5
ISO7176-7	Handgrip
height		870mm	ISO 7176-7
ISO7176-22	Effective seat
width		425mm
ISO 7176-5	Folded width		290mm	ISO 7176-7
ISO7176-22	Seat surface
height at front
edge		488mm
ISO 7176-5	Net weight		19.7kg	ISO 7176-7
ISO7176-22	Backrest angle		11.6°
ISO 7176-5	Maximum
occupant mass		136kg
(300 lbs)	ISO 7176-7
ISO7176-22	Backrest
height		440mm
ISO 7176-5	Required
width
of
angled
corridor		1000mm	ISO 7176-7
ISO7176-22	Footrest
to
seat distance	430mm	550mm
ISO 7176-5	Required
doorway entry
depth		1270mm	ISO 7176-7
ISO7176-22	Leg to seat
surface angle		107.2°
ISO 7176-5	Required
corridor width
for
side
opening		1170mm	ISO 7176-7
ISO7176-22	Armrest
to
seat distance		270mm
ISO 7176-3	Static stability
downhill		14.6°	ISO 7176-7
ISO7176-22	Front location
of armrest
structure		270mm
ISO 7176-3	Static stability
uphill	14.6°	16.5°	ISO 7176-7
ISO7176-22	Distance
between
armrest		430mm
ISO 7176-3	Static stability
lateral
orientation	11.6°	17.5°	ISO 7176-7
ISO7176-22	Footrest length		55mm
ISO 7176-1	Static stability
forward	16.5°	16.8°	ISO 7176-7
ISO7176-22	Handrim
diameter		530mm
ISO 7176-1	Static stability
rearward	Over 25°	Over 25°	ISO 7176-7
ISO7176-22	Horizontal
location of
axle		20mm
ISO 7176-7
ISO7176-22	Front
wheel
diameter		190mm	ISO 7176-7
ISO7176-22	Rear
wheel
diameter		600mm

The wheelchair confirms to the following standards:

a) Requirements and test methods of static, impact and fatigue strengths (ISO 7176-8) Yes M

Yes প্র

b) Requirements for resistance to ignition in accordance with ISO 7176-16

Note:

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About the dimensions: The wheelchair can be equipped with the hanging leg, including the ordinary hanging leg and the orthopaedic hanging leg (for wheelchairs with leg supports and/or foot supports). 1270mm length is the full overall length when being adjusted to the maximum length position which equipped with the orthopaedic hanging leg (overall length with legrest). 1160mm length is the full length of a regular leg-mounted wheelchair.

6. Indication for Use / Intended Use of Device

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

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7. Summary of Substantial Equivalence

	Proposed Device	Primary predicate device	Secondary predicate device	Comparison
510k Number	K180309	K170517	K151797	------
Product Code	IOR	IOR	IOR	Same
Proprietary Name	Manual Wheelchair W54	Merits Model R106/R136 Rehab Wheelchair	Nuocande Plastic Manual Wheelchair Model NKD L07
Model	W54	R106, R136	NKD L07	-------
Manufacturer	Jiangsu Jumao Medical Equipment Co., Ltd.	Merits Healthcare Industries. (suzhou) Co., LTD.	Ningbo Lecount Medical Technology Co., Ltd.
Indications for Use	The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.	The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.	The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees.	Similar
The basic descriptions for intended use of the three devices are the same.
The inclines of the proposed device is bigger than that of the predicate device K151797
The difference does not affect the effectiveness and safety.
Basic Design	W54 is a mechanical	The Merits Model R106/R136	Four wheels, a plastic frame	Same

Table 1 Comparison to Predicate Device

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| | wheels, a steel frame and a | wheelchairs.
They | is flame resistant. | |
|------------|------------------------------------|------------------------------------|------------------------------------|-------------------------------|
| | textilene upholstery that is | adjustable headrest, adjustable | | |
| | flame resistant. | armrests, cozy ergonomics | | |
| | | seat and multiple axle position. | | |
| | Steel (Frame, crossbrace, back | | | |
| | cane, armrest, wheel
lock. | | | Similar |
| | footrest, front fork),
hard | | | The frame material of the |
| | plastics (handgrip, rear wheel, | | | proposed device is same as |
| | handrim,
castor, footplate, | | | that of the predicate device |
| | housing),
castor
flame | | Steel (wheel rim and caster | K170517. |
| | resistant fabrics (seat and back | Frame Material: Steel | rim), hard plastics (Frame), | The seat and back upholstery |
| Materials | upholstery)
flame | Seat/Backrest
Cozy
Pad: | (armrest) and
PU
flame | material of the proposed |
| | retardant
sponge
(seat | Ergonomics PU Foam | resistant fabrics (seat) | device is same as that of the |
| | stuffing), armrest pad, tire of | | | predicate device K151797. |
| | caster and rear wheel (PU), all | | | Other difference does not |
| | kinds of pipe plugs and pipe | | | affect the effectiveness and |
| | shroud for the frame and steel | | | safety. |
| | parts (PP) | | | |
| | Back upholstery, handgrip, | Back upholstery, handgrip, | upholstery, handgrip,
Back | |
| | back cane, arm pad, armrest, | back cane, arm pad, armrest, | back cane, arm pad, armrest, | |
| | seat upholstery, seat extension, | seat upholstery, seat extension, | seat upholstery, seat extension, | |
| Components | handrim,
wheel, wheel,
rear | rear
wheel, wheel,
handrim, | wheel, wheel,
handrim,
rear | Same |
| | anti-tipper,
wheel
lock, | anti-tipper,
wheel
lock, | anti-tipper,
wheel --
lock, | |
| | footrest,
crossbrace,
frame, | crossbrace,
frame,
footrest, | frame,
footrest,
crossbrace, | |

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1	Jiangsu Jumao Medical Equipment Co., Ltd.
---	-------------------------------------------	--	--	--

| Occupant mass
group | footplate, caster, caster
housing, front fork. | footplate, caster, caster
housing, front fork. | footplate, caster, caster
housing, front fork. | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Occupant mass
group | III | III | II | Same
The occupant mass group of
the proposed device is same as
that of the predicate device
K170517. |
| Control Mode | Mechanical | Mechanical | Mechanical | Same |
| Physical Dimension | 1160mm × 610mm × 890mm
(depth × width × height)
Note: Physical dimension is
the dimension when the device
is equipped with the ordinary
hanging leg (without leg
supports and/or foot supports),
and the Overall length with
legrest is 1270mm. | Model R106: 47.5" (±1") ×
28-32" (±1") × 42" (±1")
i.e. 1026mm × 711mm ~
813mm × 1067mm
Model R136: 44.5" (±1") ×
26-30" (±1") × 42" (±1")
i.e. 1130mm × 660mm ~
762mm × 1067mm | 1090mm × 730mm × 850mm
(depth × width × height) | Similar
The three physical dimensions
are different. The difference
does not affect the
effectiveness and safety. |
| Total Mass | 19.7kg | Model R106: 89 lbs / 40.4kg
Model R136: 62 lbs / 28.1kg | 19kg | Similar
The three total masses are
different. The difference does
not affect the effectiveness and
safety. |
| Weight capacity | 300lb (136kg) | 300 lbs (136kg) | 220 lbs (100kg) | Same
The weight capacity of the |
| | | | | proposed device is same as
that of the predicate device
K170517. |
| | | Width: 16-20"(406-508mm)
Height: Model R106: 19-21"(483-533mm); Model R136: 21"(533mm)
Depth: 18-20"(457-508mm) | 411 (depth) x 447 (width) x 365 (height) mm | Similar
The three seat dimensions are
different. The difference does
not affect the effectiveness and
safety. |
| Seat dimension | 470mm × 425mm × 488mm
(depth × width × height) | | | |
| | | Height Adjustable (8"~12") | Non flip back/Non height adjustable | Similar
The armrest stucture of the
proposed device is same as
that of the predicate device
K151797, but differene form
K170517. The difference does
not affect the effectiveness and
safety. |
| Armrest | Non flip back/Non height adjustable | | | |
| | | Model R106: Multiple
Model R136: Fixed | Offset axle, Quick release axle | Same
The rear axle stucture of the
proposed device is same as
that of the predicate device
K151797 and Model R106 of
K170517. |
| Rear Axle | Offset axle, Quick release axle | | | |
| | 610mm(24") | Model R106: 610mm(24")
Model R136: | 585mm (23") | Same
The real wheel diameter of the |
| Real Wheel | | | | |
| | | | | |
| | | 317.5mm(12-1/2") | | proposed device is same as |
| | | | | that of the predicate device |
| | | | | K170517. |
| | | | | Similar |
| | | 177.8mm (7") | 190mm (8") | The casters diameter of the |
| | | | | subject device is same as that |
| Casters | 190mm(8") | | | of the predicate device |
| | | | | K151797 and of larger than |
| | | | | K170517. The difference does |
| | | | | not affect the effectiveness and
safety. |
| | | | | Similar |
| Headrest | None | Adjustable | / | The difference does not affect
the effectiveness and safety. |
| | | | | Similar |
| Back Recline | 11.6° | 9°~57° | / | The difference does not affect
the effectiveness and safety. |
| | | | | Similar |
| Seat Tilt | 6.2° | 4°~34° | / | The difference does not affect
the effectiveness and safety. |
| Elevating Legrest | Standard | Standard | Standard | Same |
| | Required width of angled | Model | | Similar |
| Turning Radius | corridor: 1000mm; Required | R106:30"35.8"(76.5cm91c
m) | / | The difference does not affect
the effectiveness and safety. |
| | doorway entry depth: | | | |
| | 1270mm; Required corridor
width
for
side
opening:
1170mm | Model
R136:32"38.1"(81.5cm96.8
cm) | | |
| Shear Reduction | Aligned Backrest Recline &
User Pivot Points | Aligned Backrest Recline &
User Pivot Points | | Same |
| Wheel Lock | Pull to Lock | Pull to Lock | Pull to Lock | Same |
| Frame Construction | Foldable Frame | Fixed Frame (Not foldable) | Foldable Frame | Same |
| Color | Black | / | Yellow | ------- |
| Standard | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22
ISO10993-1
ISO10993-5
ISO10993-10 | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22
ISO10993-1
ISO10993-5
ISO10993-10 | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22 | Same |

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Jiangsu Jumao Medical Equipment Co., Ltd.

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Note: the purpose of the secondary predicate device for comparison is to be the in terms of basic design, components, armrests, rear axles, casters, elevating legrest, wheel lock and frame structure, and to provide references in terms of substantial equivalence.

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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 "Mechanical Wheelchair W54" 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 and
manoeuvring 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

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 W54" 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.

Clinical data is not needed for manual wheelchair cleared by the 510(k) process.

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

9. Non-Clinical Tests Performed:

The following testing was performed on the "Mechanical Wheelchair W54" in accordance with the requirements of the design control regulations and established quality assurance procedures.

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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 manoeuvring 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/C1:2010 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. Biocompatibility

Type of contact: Skin contact duration category A