(196 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and standard testing of a manual wheelchair. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies.
No
A therapeutic device is one that treats or alleviates a disease, injury, or condition. A wheelchair provides mobility assistance but does not directly treat or alleviate a medical condition.
No
The device description and intended use clearly state that the APEX Manual Wheelchair is designed to provide mobility for individuals. There is no mention of it being used for the diagnosis of any condition or disease.
No
The device description clearly outlines a physical, mechanical wheelchair constructed from materials like aluminum alloy and carbon fiber, with components such as frames, wheels, axles, and brakes. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Manual Wheelchair" intended to "provide mobility to persons limited to a sitting position." This is a mechanical device used on the body for mobility, not for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical components or functions of an IVD, such as:
- Analyzing biological samples
- Reagents or assays
- Diagnostic testing
- Measuring biomarkers
The information provided describes a medical device used for physical support and mobility, which falls under a different regulatory category than IVDs.
N/A
- Not Found
Intended Use / Indications for Use
The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position.
The Apex wheelchairs are traditional rigid wheelchairs. They are made of aluminum alloy or carbon fiber. The frame which utilizes a standard geometry that creates a cantilever like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the carbon fiber camber tube via stainless steel axles.
On the front end of the frame are assembled two aluminum caster mount. Caster forks are mounted to these mounts via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.
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)
The APEX Manual Wheelchairs have been tested to the following standards;
- ISO 7176-1:1999 Determination of Static Stability
- ISO 7176-3:2012 Determination of Effectiveness of Brakes
- ISO 7176-5:2008 Determination of Overall Dimensions, Mass and Maneuvering Space
- ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
- ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength
- ISO 7176-15 Requirements for Information Disclosure, Documentation and Labeling
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2016
Motion Composites Stephane Le Beau Marketing and International sales coordinator 519 J. Oswald Forest, suite 101 Saint-Roch-de-l'Achigan, Quebec City, J0K 3H0 Canada
Re: K161425
Trade/Device Name: APEX Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 28, 2018 Received: November 7, 2016
Dear Stephane Le Beau:
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 device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161425
Device Name APEX Manual Wheelchair
Indications for Use (Describe)
The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
APEX Manual Wheelchair
Image /page/3/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized "M" inside of a circle on the left, and the words "MOTION" and "COMPOSITES" in a bold, sans-serif font on the right. Below the logo is the text "510(k) Premarket Notification".
Motion Composites APEX Manual Wheelchair 510(k) Summary
l. SUBMITTER
Motion Composites 519 J - Oswald Forest Suite 101 Saint-Roch-de-l'Achigan Quebec, Canada JOK 3H0 Phone: (450) 588-6555 Fax: (450) 588-0200 Email: info@motioncomposites.com Web Site: www.motioncomposites.com
II. DEVICE
Name of Device: APEX Manual Wheelchair Common or Usual Name: Manual Wheelchair Classification Name: Wheelchair, Mechanical (21 CFR 890.3850) Regulatory Class: I Product Code: IOR
lll. PREDICATE DEVICE
Sunrise Medical Quickie Q7 Manual Wheelchair K123975 Helio C2 Manual Wheelchair K120628
IV. DEVICE DESCRIPTION
The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position.
The Apex wheelchairs are traditional rigid wheelchairs. They are made of aluminum alloy or carbon fiber. The frame which utilizes a standard geometry that creates a cantilever like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the carbon fiber camber tube via stainless steel axles.
On the front end of the frame are assembled two aluminum caster mount. Caster forks are mounted to these mounts via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.
4
Image /page/4/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized circle with a black swoosh inside, followed by the words "MOTION" and "COMPOSITES" stacked on top of each other in a bold, sans-serif font. Below the logo, the text "510(k) Premarket Notification" is displayed.
Device Function
Device function is dependent solely upon the wheelchair user. It does not function on its' own in any manner. The wheelchair user controls motion, speed and direction by propelling themselves using the hand rims located on the rear wheels.
Scientific Concepts
There are no complex scientific concepts related to the APEX manual wheelchair. It's a simple, basic, manually operated mobility device.
Significant Physical and Performance Characteristics:
Design:
- The APEX utilizes a 2 sided aluminum or carbon fiber frame tubes that are linked by rigid ● cross-members improving greatly rigidity over regular interconnected side frames.
- . The 2 rigid links called «Rigidizers» by Motion Composites are set at the front and rear of the frame camber tube. The 3 components of the front rigidizer tube, rear rigidizer tube and the camber tube serves to increase the rigidity of the frame. The camber tube also serves to receive the rear wheel on each side.
- A set of adjustable axle plates are attached vertically to each side frame and provide the . wheelchair with ability to move the rear wheel position forward and backward in order to give the user an adjustment as to the center of gravity of the wheelchair. The vertical position can be also adjusted to set the height of the user on the wheelchair. These rear axle plates are linked by the camber tube to limits torsion and flexion for improved propulsion.
Materials:
Materials used are:
- Aluminum or Carbon fiber frame, support members ●
- Aluminum or Carbon fiber Components ●
- Aluminum wheels
- Steel fasteners and components
- Polyurethane tires
- Fabric covered foam upholstery ●
5
Image /page/5/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized circle with a curved line inside, followed by the words "MOTION" and "COMPOSITES" stacked on top of each other in a bold, sans-serif font. Below the logo, the words "510(k) Premarket Notification" are written in a smaller font.
Physical Properties:
The APEX consist primarily of an aluminum or carbon fiber frame assembly, a back rest frame, seat and back rest upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel pivoting casters for turning.
V. INDICATIONS FOR USE
The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position. This is identical to the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technology and principle of operation for the APEX, Helio C2 and the Quickie Q7 are identical. They all consist of an aluminum frame or carbon fiber frame with a seat and large rear wheels with hand rims for propelling the device. Smaller, pivoting type casters are mounted on the front of the chairs for steering and turning.
Device function is dependent solely upon the wheelchair user. They do not function on their own in any manner. The wheelchair user controls motion, speed and direction by propelling themselves using the hand rims located on the rear wheels.
If both rear wheels are propelled at the same time, the chair will move forward in a straight direction. If only the left rear wheel is propelled the chair will turn to the right. If only the right rear wheel is propelled the chair will turn to the left.
Discussion of Similarities and Differences:
The APEX wheelchairs are substantially equivalent to the predicate Quickie Q7 (K123975) or Helio C2 wheelchairs (K120628) in technology, function, performance and materials. They have the same indications for use which is to provide mobility for persons restricted in a sitting position.
The frame width, depth and the back cane heights vary slightly between the devices, but since these are only used to better fit the device to the user's needs, these slight differences do not cause any concerns for the safety and effectiveness of the weight limit is similar within 15 pounds for all devices. The Quickie Q7 is at 265 lbs. and the Helio C2 and APEX is at 250 lbs. and is clearly stated in the proposed device labeling.
6
Image /page/6/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized circle with a black design inside, along with the words "MOTION" and "COMPOSITES" in a bold, sans-serif font. Below the logo, the text "510(k) Premarket Notification" is displayed.
With regard to accessories and add-ons, all devices offer the same types of armrests, backrests, hangers and footblates. These accessories are made of the exact same materials for all devices and thus do not raise any questions for the safety and effectiveness of the APEX wheelchairs. The same can be said of back types and extension tubes.
Axle plates for all devices are made out of the same material; however, the actual mounting systems differ slightly. The Quickie Q7 and APEX axle plates are mounted vertically on a single tube on each side of the frame and the Helio C2 are mounted vertically on 2 tubes on each side of the frame.
The mechanical difference found on the Quickie Q7 and Apex permits a larger range of adjustment of the Center of Gravity for the user. It does not raise any concerns for the safety and effectiveness of the device and actually improves the precision of the adjustment.
The same can be said for the caster housing that holds the front wheel into place. While the caster housing of the predicate device and those of the APEX are made all made of aluminum, the mounting system of the APEX casters housing is patented and thus slightly different from the one found on the Quickie Q7 or Helio C2 wheelchairs.
This mounting system embeds the caster housing directly into the fork stem support, and allows adjusting the angle of the castes for an efficient and more comfortable position for the user. The caster housing also imbeds a level to make sure the fork and casters are perpendicular to the ground, thus providing a better overall experience to the wheelchair user when turning and moving straight forward.
This small difference as well does not raise any concerns as far as the safety of the overall product against the predicate device, since all casters offer the same effectiveness as per the APEX successfully obtaining its ISO certification.
The seat and back upholstery offering of the APEX is equivalent to the one found on the predicate devices. It is made of high-quality durable sailcloth, which consists of 1000 denier fill and 250 denier wrap.
The rear wheels and hand rims of the predicate device and the APEX wheelchairs are offered in a wide range of different options. They are made of the same materials and are widely used in the wheelchair industry. The specific type, material and size of the wheels are chosen depending on the user's needs. These differences do not raise any concerns for the safety and effectiveness of the APEX wheelchairs. We also note the wheel locks are the same on all devices. The predicated devices were tested under the older ISO 7176-8 (1st Edition, 1998-07-15) standard for parking brakes, it's uncertain that these brakes could meet the new ISO 7176-8 (2nd Edition 2014-12-15) standard. The APEX push-to-lock and Graid-Aid brakes pass the new standard but when testing the pull-to-lock parking brakes we found that they failed. For this reason, the APEX will not offer an option with the pull to lock parking brake. This does not influence the ability of the user to park the
7
Image /page/7/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized circle with a wing-like shape inside, followed by the words "MOTION" and "COMPOSITES" stacked on top of each other. Below the logo, the text "510(k) Premarket Notification" is displayed.
wheelchair, it only limits the number of options of parking brakes available. For this reason, Motion Composites feel that the APEX is offering a safer parking brake option.
Based on the above discussion, Motion Composites believes that the APEX wheelchairs are substantially equivalent to the Quickie Q7 wheelchair (K123975) and the Helio C2 (K120628). While there are some differences between the APEX and its predicate, these differences are minor and do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.
VII. PERFORMANCE DATA
The APEX Manual Wheelchairs have been tested to the following standards;
- ISO 7176-1:1999 Determination of Static Stability
- ISO 7176-3:2012 Determination of Effectiveness of Brakes
- ISO 7176-5:2008 Determination of Overall Dimensions, Mass and Maneuvering
- Space
- ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
- ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength
- ISO 7176-15 Requirements for Information Disclosure, Documentation and Labeling
The performance data for the Quickie Q7 is not published. However, on page 13 of the Quickie Q7 Owner's Manual, the following statement is made;
This wheelchair has been dynamically tested in a forward-facing mode with the specified crash test dummy, restrained by both pelvic and upper-torso belts in accordance with ANSI/RESNA WC Vol 4 Section
This statement indicates that the Sunrise Quickie Q7 has been tested to at least some of the ANS//RESNA standards. These standards are comparable to the ISO 7176 standards which were used to test the Motion Composites APEX wheelchairs. (Note that a copy of the Quickie Q7 and Helio C2 Owner's Manual are provided in Volume 10 of this submission).
Further, manual wheelchairs are subject to the 1995 FDA guidance document entitled: "Guidance Document for the Preparation of Premarket Notification [(510(k)] Applications Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles." This guidance includes various safety and performance requirements that the Quickie 7 would have to have met or addressed prior to being cleared by FDA. Meeting these requirements also serves as a basis for substantial equivalence of the APEX to its' predicate.
VIII. CONCLUSIONS:
Performance testing and compliance with FDA guidance for manual wheelchairs supports the safety of the APEX manual wheelchair. Since the predicate device was cleared based in part on these data, conformance with the same requirements demonstrates that the APEX will perform as intended in the specified use conditions.
8
Image /page/8/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized circle with a wing-like shape inside, followed by the words "MOTION COMPOSITES" in a bold, sans-serif font. Below the logo, the text "510(k) Premarket Notification" is displayed.
Further, technology, principle of operation and indications for use between APEX, the Quickie Q7 and Helio C2 are identical. This demonstrates that they perform comparably to the predicate device that is currently marketed for the same intended use. Therefore, the APEX manual wheelchair is substantially equivalent to the Quickie Q7 and Helio C2 devices.
9
APEX Predicate Device Comparison
| Feature/Specification | Sunrise Medical LLC Quickie Q7
(K123975) | Motion Composites Helio
(K120628) | APEX |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Quickie Q7 Wheelchair is a
manually operated device intended to
be used as a means of mobility for
persons restrict to a sitting position. | The Helio wheelchair is a manually
operated device intended to be used
as a means of mobility for persons
restrict to a sitting position. | The APEX wheelchair is a manually
operated device intended to be used
as a means of mobility for persons
restrict to a sitting position. |
| Primary Materials | Aluminum | Carbon Fiber | Carbon Fiber and Aluminum |
| Folding Method | Rigid wheelchair | Collapsible Cross-brace | Rigid wheelchair |
| Frame Width | 12″ to 20″ | 14″ to 22″ | 12″ to 20″ |
| Overall width | 19″ to 27″ | 21 1/2" to 29 ½" | 18 ½" to 33 ¼" |
| Seat Depth | 12″ to 20″ | 15″ to 21″ | 12" to 20" |
| Back Heights | 8″ to 20″ | 9″ to 21″ | 9″ to 21″ |
| Weight Limit : | 265 lbs. | 250 lbs. | 250 lbs. |
| Front Seat height : | 16″ to 21″ | 13½" to 21 ¼" | 14" to 20" |
| Chair Weight
Standard configuration | 14. lbs.
Without wheels | 16.5 lbs.
Without footrests and wheels | 10.7 lbs. without wheels Aluminum
model
9.2 lbs. without wheels carbon fiber
model |
| Warranty | Lifetime on frame | Lifetime on frame | Lifetime on frame |
| Armrests | -Padded Swing Away
-Single Post Height Adjustable
-T-Shaped Armrests - Height adjustable
Tubular Swing-away | -Flip back armrest, removable, height
adjustable (by user, no tool required)
-T-Shaped, Single Post removable,
Height adjustable (by user, no tool
required)
-Tubular Swing-away | -T-Shaped armrest, removable, height
adjustable (by user, no tool required)
-Tubular Swing-away |
| Front end types | Welded to frame | Mounted to frame Swing-in Swing-out | Factory clamped to the frame |
| Back Type | -Folding Lock-Down Angle Adjustable
-Non-Folding Angle-Adjustable
-Depth Adjustable | -Straight
-8 degree bend back
-Adjustable angle- straight or 8 degree
bend | -Folding Lock-Down Angle Adjustable
straight with or with-out push handle
- Ultralight Folding without push
Handle |
| Footrest | Integrated to the frame | Flip in, flip out; 60°, 70° , 90°,
elevating legrest | Integrated to the frame |
| Footplates | -Aluminum Tubular
-Aluminum Tubular w/ Snap-on Cover
-Angle Adjustable Flip Back
-Platform
-Ultra Lite Platform | -Standard non adjustable
-Angle Adjustable Oversized | -Aluminum Tubular with or without
platform
-Platform angle adjustable - Flip-back platform |
| Back Upholstery | Standard, Tension Adjustable | Standard, Tension Adjustable | Standard, Tension Adjustable |
| Axle Plates | -Adjustable COG (1"-4")
-Adjustable Extended COG (0"-3") | Standard adjustable
Extended adjustable for Amputee | Standard post type Adjustable
COG (0"-5") |
| Wheel sizes | 20,22,24, 25,26 " | 20 ,22,24, 25, 26 " | 20 ,22,24, 25, 26 " |
| Wheel types | -Spoke
-Composite Mag
-Spinergy
-Mountain | -Spoke
-Composite Mag
-Spinergy | -Spoke
-Composite Mag
-Spinergy |
| Tire types | -Pneumatic regular and high pressure
-Pneumatic w/ airless insert
-Full and low profile polyurethane | -Pneumatic regular and high pressure
-High and low profile polyurethane
-Hard Urethane | -Pneumatic regular and high pressure
-High and low profile polyurethane
-Hard Urethane |
| Handrims | -Aluminum Anodized
-Plastic Coated
-Natural Fit
-Spinergy Flex Rim | -Aluminum Anodized
-Plastic Coated
-Natural Fit
-Spinergy Flex Rim
-Surge Handrim | -Aluminum Anodized
-Plastic Coated
-Natural Fit
-Spinergy Flex Rim
-Surge Handrim |
| Caster Sizes | 3", 4",5", 6" | 3″, 4″,5″, 6″, 8″ | 3", 4",5", 6" |
| Feature/Specification | Sunrise Medical LLC Quickie Q7
(K123975) | Motion Composites Helio (K120628) | APEX Wheelchair |
| Caster types | Polyurethane, semi-pneumatic, Soft
Roll, Pneumatic | Composites wheels, Pneumatic, Soft
Roll | Composites wheels, Pneumatic, Soft
Roll |
| Fork Sizes | 3",4",5",6",7" | 3",4",5",7" | 4 ¾" |
| Fork Stem Sizes | Std,+3/4",+1 ½" | Std, +1, +2 | Std, +1, +2 |
| Caster Options | Multi-position fork caster, pin locks | Multi-position fork caster, pin locks | Multi-position fork caster |
| Wheel Locks | Push to lock, pull to lock, scissor lock | Push to lock, pull to lock, scissor lock | Push to lock, scissor lock |
| Anti-tip tubes | Yes | Yes | Yes |
| Target population | Restricted to a sitting position | Restricted to a sitting position | Restricted to a sitting position |
| Standards | Unknown | ISO 7176 - (1, 3, 5, 7, 8 & 15) | ISO 7176 - (1, 3, 5, 7, 8 & 15) |
10