Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and structural aspects of a manual wheelchair, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is a mechanical wheelchair, which is used to provide mobility to persons restricted to a sitting position due to illness, injury, or disability, fitting the definition of a therapeutic device as it treats or mitigates a condition (lack of mobility).

Diagnostic

No

Explanation: The device is a mechanical wheelchair, which is a mobility aid, not a diagnostic tool. Its intended use is to provide mobility, and the description and performance studies focus on its physical characteristics and safety standards, not on diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like a frame, wheels, brakes, and other mechanical parts, indicating it is a hardware device, not software-only.

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 "providing mobility to persons restricted to a sitting position." This is a physical function, not a diagnostic one.
Device Description: The description details the mechanical components of a wheelchair, which are used for physical support and movement.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
Performance Studies: The performance studies focus on the physical characteristics and safety of the wheelchair (stability, brakes, dimensions, strength, etc.), not on diagnostic accuracy or performance.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wheelchair does not perform any such function.

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

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

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

Main materials:
Frame: high strength aluminum alloy 6061 - T6, external diameter of Ø 25.4 mm, wall thickness of 2.0 mm.
Armrest: high strength aluminum alloy 6061 - T6, external diameter of Ø 19 mm, wall thickness of 1.5 mm
Brake assembly: aluminum alloy
Seat and backrest: flame resistant fabrics
Tire: PU

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)

Non-Clinical Tests Performed:

Safety and performance:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs – Part 13: Determination of friction of test surface
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures

Biocompatibility:
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity

Usability Study:
The 15 participants read the User Manual before initial use of the device. They can understand the questions and answer them. The 15 participants can operate the device referring to the User Manual.
Based on the verification & validation testing records provided, we concluded that the Manual Wheelchair, Model SYIV100-LQXAL2482-407 is considered to meet the usability requirement as defined in the verification & validation test report.

Key Results:
"Manual Wheelchair SYIV100-LQXAL2482-407" met all relevant requirements in the test standards.
The proposed devices are as safe, as effective and perform as well as the predicate device.

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

Not Found

Predicate Device(s):

K181795

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

March 14, 2022

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

Re: K213790

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

Dear Shanfeng Jiang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K213790

Device Name Manual Wheelchair SYIV1OO-LQXAL2482-407

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date of Summary Preparation: Nov,08, 2021

1. Submitter's Identifications

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

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

2. Correspondent's Identifications

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

3. Name of the Device

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

4. The Predicate Devices

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AST Model MA012 and MS019 Rehab Wheelchair K181795

5. Device Description

Operating principle

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.

【Structure composition

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

【Main materials

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

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

Brake assembly: aluminum alloy

Seat and backrest: flame resistant fabrics

Tire: PU

6. Intended Use of Device

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

7. Summary of Substantial Equivalence

Table 1 Comparison to Predicate Device

	Proposed Device	Predicate device	Comparison
510k Number	K213790	K181795	------
Product Code	IOR	IOR	Same
Proprietary Name	Manual
Wheelchair
SYIV100-LQXAL2482
-407	AST Model MA012 and
MS019 Rehab Wheelchair	------
Model	SYIV100-LQXAL2482
-407	MA012 and MS019	------
Manufacturer	Guangdong Shunde LQX
Health Technology Inc.	Sichuan AST Medical
Equipment Co., Ltd.	------
Indications for Use	The device is intended
for medical purposes to
provide mobility to
persons restricted to a	The AST Model MA012 and
MS019 Rehab Wheelchairs
are to provide mobility to
persons limited to a sitting	Same
	sitting position.	position.
Type of Use	Over-the-counter	Over-the-counter	Same
Basic Design	1. The wheelchair
adopts aluminum alloy
tube frame and
ergonomic design, the
surface of the piano
paint treatment, to
achieve high strength,
high load bearing, light
weight, small volume,
and at any time folding
structure, do not take up
space, easy to carry;

Seat depth and
backrest angle can be
adjusted according to
human comfort.
Backrest height can
be adjusted.
The armrest of the
wheelchair can be lifted
back, the height of the
armrest can be adjusted,
the front and back can
slide, the footplate can
rotate, and the angle can
be adjusted.
Front and rear wheels
adopt PU solid tire,
fireproof and breathable
seat cushion and
backrest.
Backrest can be back
folding.
The device can be
equipped with drum
brake, easy for the
caregiver control and
down the steep slope
control flexibility and
stability. | The AST Model MA012 and
MS019 Rehab Wheelchair are
manual wheelchairs.
They have adjustable
armrests, and multiple axle
position. The casters are
6"/7"/8" PU wheels with
height adjustable forks and
the rear wheels are
20"/22"/24"*1-3/8"
polyurethane (MA012 and
MS019).
Aluminum frame with liquid
coated and folding backrest
Flip-up and detachable
armrest PU pad
Detachable footrest
Front casters PU tires and
quick release rear wheel PU
tires
Nylon cushion | Similar
The structure
and materials
of main
frame of the
proposed
device and
predicate
device are
same, only
individual
materials are
different,
such as back
upholstery
and seat
upholstery,
etc.
The
differences
do not raise
safety and
effectiveness
of the
proposed
device. |

5

6

| | Materials | | with aluminum alloy
brake assembly.
9. There is Equipped
with anti-overturn
device.
Frame: high strength
aluminum alloy 6061 -
T6, external diameter of
$Ø$ 25.4 mm, wall
thickness of 2.0 mm.
Armrest: high strength
aluminum alloy 6061 -
T6, external diameter of
$Ø$ 19 mm, wall
thickness of 1.5 mm
Brake assembly:
aluminum alloy
Seat and backrest: flame
resistant fabrics
Tire: PU | AST Model MA012 Rehab
Wheelchair: Aluminum frame
with liquid coated and folding
backrest
Flip-up and detachable
armrest PU pad
Detachable footrest
Front casters PU tires and
quick release rear wheel PU
tires
Nylon cushion | Similar
The Main
structural
materials and
wheels
materials are
same.
The
differences
do not raise
safety and
effectiveness
of the
proposed
device. |
|-----------|--------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Components | | The device is mainly
composed of painted
frame, fireproof and
breathable seat cushion,
armrest, backrest, hand
push tube, detachable
leg, 8-inch front wheel,
24-inch rear wheel,
brake group and
anti-overturn device. | AST Model MA012 Rehab
Wheelchair: Main frame,
handle sleeve, back
upholstery, seat upholstery,
armrest pad, armrest, side
panel, front casters, rear
wheel, legrest, footplate,
brake, front fork, cross-
brace. | Same
Although the
expressions
are different,
the main
components
are same. |
| | Control Mode | | Mechanical | Mechanical | Same |
| | | Length | 1070mm | Model MA012:
1173mm( $\pm$ 1mm) | Similar
The two
physical |
| Dimension | | Width | 625mm | Model MA012:
645mm ( $\pm$ 1mm) | dimensions
are different.
The |
| | | | | | |
| | | Height | 1035mm | Model MA012:
892mm ( $\pm$ 1mm) | difference
does not
affect the
effectiveness
and safety |

7

| Net weight | 38.3 lbs/17.4kg | Model MA012:
17.2kg/38lbs | Similar
The
proposed
device
is
heavier than
the predicate
device. | |
|------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Weight capacity | 300lbs/136kg | Model MA012:
300lbs/136kg | Same | |
| Seat width | 446mm(17.6") | Model MA012:
16"(406mm)
18"(457mm)
20"(508mm) | Similar
Different
seat sizes do
not raises the
safety
and
effectiveness
of
the
device. | |
| Seat height | 518mm(20.4") | Model MA012:
19.7"(500mm) | | |
| Seat depth | 495mm(19.5") | Model MA012:
16"-20"
(406mm-508mm) | | |
| Frame type | foldable | foldable | Same | |
| Cross-brace
configuration | 18" | 14", 16", 18", 20" or 22" | Same
Cross-brace
sizes
of
predicate
device
include with
that
of
proposed
device. | |
| Back style | Fixed | Model MS019: Fixed
Model MA012: Adjustable | Same | |
| Anti-tippers | Optional | Optional | Same | |
| Wheel
construction | Quick release | Quick release | Same
Wheel
construction
of proposed
device
is
same
as
predicate
device model
SIVFH2A10
2. | |
| Tires | Front:200mm (8")
Rear: 600mm(24") | Front: 6",7",8"
Rear: 20",22",24" | Same
The
tires | |
| | | | sizes of
proposed
device are
included to
those of
predicate
device. | |
| | Armrest | Flip back armrest | Model MA012: Height
Adjustable desk length
armrest, Flip back
Model MS019: Fixed or
adjustable height; desk or full
length; removable | Similar
The height of
armest of
proposed
device can
not be
adjustable. |
| | Foot rest | Optional/ swing away | Optional/ swing away | Same |
| | Rear Axle Position | Single | Multiple | Similar
The rear axle
of proposed
device has
only one
size. |
| | Frame Material | high strength aluminum
alloy | Model MA012: Aluminum
Model MS019: Steel | Same
The frame
material of
proposed
device is
same as
predicate
device model
MA012. |
| | Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same |
| | 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 | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22
ISO10993-1
ISO10993-5 | Same |
| | ISO10993-10 | ISO10993-10 | | |
| | | | | |

8

9

8. Substantial Equivalence discussion:

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

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

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

Table 2: Comparison of Performance Testing

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

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

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

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

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

10

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

9. Non-Clinical Tests Performed:

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

Safety and performance:

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

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

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

ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions

ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths

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

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

ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices

ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures

Biocompatibility:

ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity

10. Usability Study:

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

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

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

11

11. Conclusion:

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