(293 days)
No
The device description details a traditional manual wheelchair with no mention of AI or ML components or functionality. The performance studies are based on standard wheelchair testing protocols.
No
The device is described as a manually operated wheelchair intended for mobility, not for treating or diagnosing a medical condition.
No
The device is described as a manually operated wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly details a physical, manually operated wheelchair constructed from various materials and components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "manually operated device intended to be used as a means of mobility for persons restricted to a sitting position." This describes a physical mobility aid, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of a wheelchair (frame, wheels, seat, backrest, etc.). There is no mention of reagents, assays, or any components related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Diagnostic purposes
- Measurement of analytes
- Use in a laboratory setting
The device is a medical device, specifically a mobility aid, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
Product codes
IOR
Device Description
The helio is a traditional folding cross-brace wheelchair. It is made of lightweight hi-Modulus carbon fiber mixed with epoxy resin similar to what is used on existing products such as K915533. The frame utilizes one patented cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box 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 stainless steel axle receivers via stainless steel axles.
On the front end of the frame are assembled 2 aluminum caster housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 back tubes are inserted to the desired height. Backrest upholstery is affixed to the back tubes. Armrests receivers bolt onto the rear of each side frame. Individual swing away armrests are then inserted into the receivers. If flip back armrests are chosen, a receiver is mounted onto the front of each side frame to catch the forward most section of the arm and the rear mounting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the frame.
Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Footrests with footplates attach at the front of the chair. There is a plug at the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is inserted 90 degrees away from the frame and rotates inwards. The latch will engage once the footrest hanger is centered.
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 indicated for the pediatric population.
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 helio has been tested and found to comply with these recognized international standards:
- ISO 7176-1: Wheelchairs, part 1: Determination of static ability.
- ISO 7176-5: Wheelchairs, part 5: Determination of dimensions, mass and manoeuvring space.
- ISO 7176-8: Wheelchairs, part 8: Requirements and test methods for static, impact and fatigue strengths.
- ISO 7176-11: Wheelchairs, part 11: Test dummies.
- ISO 7176-15: Wheelchairs, part 15: Requirements for information disclosure, documentation and labeling
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows a sequence of characters that appear to be handwritten. The characters are "K120628". The characters are written in a simple, somewhat cursive style, with some connections between the letters and numbers. The image is in black and white.
Image /page/0/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized eye inside of a circle on the left, followed by the words "MOTION COMPOSITES" in all caps. There is a line underneath the words "MOTION COMPOSITES".
11/19/2012
510(K) Summary
DEC 1 9 2012
Submitter Motion Composites 519 J-Oswald-Forest Suite 101 Saint-Roch-de-l'Achigan, QC, Canada JOK 3HO
Telephone : (450)588-6555 Fax : (450) 588-0200
Contact : M. Vincent Lécuver
Trade Name : Helio Classification Name : Mechanical wheelchair Classification : Class I
Indications For Use:
The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
Predicate Devices :
The first predicate device is the Quickie 2 wheelchair for the overall safety and effectiveness of the product :
510(K) number K850536
The second predicate device is the Quickie carbon wheelchair for the safety and effectiveness of carbon fiber as the main material for frame and crossbrace in a mechanical wheelchair : 510(K) number K915533
Device Description
The helio is a traditional folding cross-brace wheelchair. It is made of lightweight hi-Modulus carbon
fiber mixed with epoxy resin similar to what is used on existing products such as K915533. The frame
519 J-Oswald Forest, suite 101, Saint-Roch-de-l'Achigan, QC, Canada JOK 3H0 T. 450 588-6555 1 866 650-6555 F. 450 588-0200 www.motloncomposites.com
Page 8 of 21
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Image /page/1/Picture/0 description: The image shows a black and white logo. The logo consists of a circle with a stylized image of a leaf or feather inside. The leaf or feather is oriented horizontally, with the tip pointing to the right.
N COMPOSITES
utilizes one patented cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box 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 stainless steel axle receivers via stainless steel axles.
On the front end of the frame are assembled 2 aluminum caster housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 back tubes are inserted to the desired height. Backrest upholstery is affixed to the back tubes. Armrests receivers bolt onto the rear of each side frame. Individual swing away armrests are then inserted into the receivers. If flip back armrests are chosen, a receiver is mounted onto the front of each side frame to catch the forward most section of the arm and the rear mounting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the frame.
Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Footrests with footplates attach at the front of the chair. There is a plug at the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is inserted 90 degrees away from the frame and rotates inwards. The latch will engage once the footrest hanger is centered.
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Image /page/2/Picture/0 description: The image shows a logo with a stylized leaf inside a circle. The leaf is positioned horizontally across the center of the circle. The leaf has a pointed tip on the left and a slightly wider, textured end on the right. A split or vein is visible within the leaf's structure, adding detail to its design.
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MOTION COMPOSITES
11/19/2012
| Description | Materials | |
|---|---|---|
| The helio wheelchair is a manually operated device | ||
| Intended Use | intended to be used as a means of mobility for persons | |
| restricted to a sitting position | ||
| Primary Frame | ||
| Materials | Composite Materials | Hi Modulus carbon fiber + epoxy resin |
| Folding Method | Collapsible Cross-Brace | Hi Modulus carbon fiber + epoxy resin |
| Frame Widths | 12" to 20" | |
| Overall Width | 19 1/2" to 27 1/4" | |
| Seat Depths | 12" to 20" | |
| Back Heights | 9" to 21" | |
| Weight Limit | 220 lbs | |
| Seat Height | 13 1/2" to 22 1/4" | |
| Chair Weight | 14.5 lbs (without footrests) | |
| Warranty | Limited Lifetime on frame | |
| Flip back Height adjustable | ||
| Armrests | T-Shaped Armrests - Height adjustable | 6061-T6 Aluminum + Plastic + Pu foam |
| Tubular Swing-away | ||
| Swing-Away | ||
| Front End Type | Fixed Front Frame | 6061-T6 Aluminum |
| Straight | ||
| Back Type | 8 degree bend back | Hi Modulus carbon fiber + epoxy resin OR 6061-T6 Aluminum |
| Adjustable angle- straight or 8 degree bend | ||
| Footrests Hangers | 60, 70 and 90 degrees hangers | 6061-T6 Aluminum |
| Composites | ||
| Footplates | Angle Adjustable Oversized | Plastic, 6061-T6 Aluminum |
| one-piece flip-up | ||
| Extension Tubes | Short, Medium, Long | 6061-T6 Aluminum |
| Back upholstery | Slip on back | Nylon #420 black |
| Adjustable tension back | Nylon #840 & #210 black | |
| Seat Upholstery | Nylon seat sling | Fire resistant Sailcloth |
| Cushion | 2" or 3" foam cushion | 1" FOAM B4130 |
| Axle Plates | 6061-T6 Aluminum | |
| Wheel sizes | 20 ,22,24, 25" 26 " | |
| Plastic Mags | Plastic + 6061-T6 aluminum hub | |
| Regular Spoke | Aluminum Rim, Stainless spoke and Aluminum hub | |
| Wheel Types | Spinergy Wire | Aluminum Rim, Stainless spoke and Aluminum hub |
| Spinergy LX | Aluminum Rim, PBO spoke and Aluminum hub | |
| Spinergy Spox | Aluminum Rim, PBO spoke and Aluminum hub | |
| Pneumatic regular and high pressure | ||
| Tire Types | Full and low profile polyurethane | Synthetic rubber and urethane |
| Hard Urethane | ||
| Aluminum Anodized | ||
| Plastic Coated (regular or high friction) | ||
| Handrims | Spinergy Flexrim | |
| Natural Fit handrim | ||
| Caster Sizes | 3" to 8" | |
| Composites wheel | Polyurethane tires | |
| Caster types | Pneumatic | Synthetic rubber and urethane |
| Fork Sizes | 3",4",5", 7" | 6061-T6 Aluminum |
| Fork Stem Sizes | std, +1 , +2 | HT4140 Steel |
| Wheel Locks | Push to lock, pull to lock, Scissor brake | 6061-T6 Aluminum |
| Anti tips tubes | Short, Medium, Long | 6061-T6 Aluminum |
| Target Population | Persons restricted to a sitting position | |
| Standards | ISO 7176 1,5,8,11,15 | |
| Tubing wall | ||
| thicknesses | 1/16" | |
| Tube Properties | Strong enough to pass ISO7176 double cycle (400 000) |
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Image /page/3/Picture/0 description: The image shows a logo that features a stylized feather inside of a circle. The feather is oriented horizontally across the center of the circle. The feather appears to be a single, solid shape with a pointed tip on the left and a slightly wider, textured end on the right. The circle is incomplete, with a small gap at the bottom.
MOTION COMPOSITES
11/19/2012
Technological comparison to the predicate device
| DEVICES | Quickie Wheelchair (K850536) | Quickie Carbon (K915533) | Helio wheelchair |
|---|---|---|---|
| Intended Use | The Quickie Wheelchair is a manually | ||
| operated device intended to be used as a | |||
| means of mobility for persons restrict to a | |||
| sitting position. | The Quickie Carbon 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. | |||
| Primary Materials* | Aluminum 6000 series | Hi-Modulus Carbon Fiber | Hi-Modulus Carbon fiber + Epoxy |
| Resin | |||
| Folding Method | Collapsible Cross-Brace | Fixed Frame | Collapsible Cross-brace |
| Frame Width | 11" to 22" | 14" to 20" | 12 " to 20" |
| Overall width | 20,5" to 28,5" | 20,5" to 28,5" | 19 ½" to 31 ½" |
| Seat Depth | 10" to 20" | 14" to 20" | 12" to 20" |
| Back Heights | 8,5" to 19" | 8,5" to 19" | 9" to 21" |
| Weight Limit : | 250lbs | 250lbs | 220 lbs |
| Seat height : | 16.75" to 22.75". | 16.75" to 22.75". | 13 ½" to 22 ½" |
| Chair Weight | |||
| (without footrests) | 27 lbs | unknown | 14.5 lbs |
| Warranty | Lifetime on frame | Lifetime on frame | Lifetime on frame |
| Armrests | Flip back Height adjustable | Flip back Height adjustable | Flip back Height adjustable |
| T-Shaped Armrests - Height adjustable | T-Shaped Armrests - Height adjustable | T-Shaped Armrests - Height adjustable | |
| Tubular Swing-away | Tubular Swing-away | Tubular Swing-away | |
| Front end types | Swing-Away | Swing-Away | Swing-Away |
| Non swing-away | Non swing-away | Non swing-away | |
| Back Type | Standard | Standard | Standard |
| Angle Adjustable | Angle Adjustable | Angle Adjustable | |
| Depth Adjustable Standard | |||
| Footrest Hangers | 60,70,90 degrees, elevating legrests | 60,70,90 degrees | 60,70,90 degrees, elevating legrests |
| Footplates | Composites, Foam, Aluminum angle | ||
| adjustable | Composites, Foam, Aluminum angle | ||
| adjustable | Composites, Aluminum angle | ||
| adjustable, one piece flip-up | |||
| Back Upholstery | Low, Medium, Tall, Adjustable, | Low, Medium, Tall, Adjustable, | Standard, Adjustable |
| Axle Plates | Standard, Curved, Amputee, Offset | ||
| Standard | Standard, Curved, Amputee, Offset | ||
| Standard | Standard, Amputee | ||
| Wheel sizes | 20,22,25,26 " | 20,22,25,26 " | 20,22,24,26 " |
| Wheel types | Spoke, Composite Mag, Spinergy, One arm | ||
| drive | Spoke, Composite Mag, Spinergy, One | ||
| arm drive | Spoke, Composite Mag, Spinergy | ||
| Wire, LX and Spox | |||
| Tire types | Pneumatic, Pneumatic w/ airless Insert | ||
| Polyurethane, Low Profile Full profile | |||
| Iron Cap | Pneumatic, Pneumatic w/ airless | ||
| insert, Polyurethane, Low Profile Full | |||
| profile , Iron Cap | Pneumatic regular and high pressure | ||
| Full and low profile polyurethane | |||
| Hard Urethane | |||
| Handrims | Aluminum, Plastic Coated, Projections | Aluminum, Plastic Coated, | |
| Projections | Aluminum, Plastic coated, high | ||
| friction, Natural Fit | |||
| Caster Sizes | 4",5",6",8" | 4",5",6",8" | 3" to 8" |
| Caster types | Polyurethane, semi-pneumatic, Soft Roll, | ||
| Pneumatic | Polyurethane, semi-pneumatic, Soft | ||
| Roll, Pneumatic | Composites wheels, Pneumatic, Soft | ||
| Roll | |||
| Fork Sizes | 3",4",5",6",7" | 3",4",5",6",7" | 3",4",5",7" |
| Fork Stem Sizes | Std,+3/4",+1 ½" | Std,+3/4",+1 ½" | std, +1 , +2 |
| Caster Options | Multi-position fork caster, pin locks | Multi-position fork caster, pin locks | Multi-position fork caster, pin locks |
| Wheel Locks | Push to lock, pull to lock, scissor lock | Push to lock, pull to lock, scissor lock | Push to lock, pull 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 | Unknown | ISO 7176 part 1, 5, 8, 11, 15, |
519 J-Oswald Forest, suite 101, Saint-Roch-de-l'Achigan, QC, Canada JOK 3HO
T. 450 588-6555 1 866 650-6555 F. 450 588-0200 www.motioncomposites.com
Page 11 of 21
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Image /page/4/Picture/0 description: The image shows the logo for Motion Composites. The logo consists of a circular graphic on the left and the words "MOTION COMPOSITES" on the right. The graphic is a circle with a stylized image of a wing or feather inside. The words "MOTION COMPOSITES" are in a bold, sans-serif font, and there is a line underneath the words.
It is Motion Composites' conclusion that the helio manual wheelchair is substantially equivalent to the
Quickie 2 manual wheelchair (K850536) and the Quickie carbon (K915533) .
Summary of Performance Testing
The helio has been tested and found to comply with these recognized international standards :
- . 16-158 ISO 7176-1 : Wheelchairs, part 1 : Determination of static ability.
- . 16-163 ISO 7176-5 : Wheelchairs, part 5 : Determination of dimensions, mass and manoeuvring space.
- . ISO 7176-8 : Wheelchairs, part 8 : Requirements and test methods for static, impact and fatigue strengths.
- 16-24 ISO 7176-11 : Wheelchairs, part 11 : Test dummies. .
- . 16-27 ISO 7176-15 : Wheelchairs, part 15 : Requirements for information disclosure, documentation and labeling
Conclusion
As stated above, Motion Composites' conclusion is that the helio wheelchair is safe, effective, complies with the appropriate medical device standards, and is substantially equivalent to the Quickie 2 and Quickie carbon wheelchair. This 510(k) Summary of Safety and Effectiveness may be copied and submitted to interested parties as required by 21CFR807.92.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2012
Motion Composites % Mr. Vincent Lecuyer Marketing Manager 519 J-Oswald-Forest, Suite 101 Saint-Roch-de-L'Achigan QC, Canada JOK 3H0
Re: K120628
Trade/Device Name: Helio ultra-light wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: November 19, 2012 Received: November 28, 2012
Dear Mr. Lecuyer:
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
6
Page 2 - Mr. Vincent Lecuyer
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -A
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/1 description: The image shows the logo for Motion Composites. The logo consists of a stylized image of a bird in a circle on the left, and the word "MOTIONCOMPOSITES" on the right. There is a line underneath the word "MOTIONCOMPOSITES".
Indications for Use
510(k) Number (if known): K120628
Device Name: Helio ultra-light wheelchair ·
Indications For Use:
The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brian D. Pullin -S
Division of Neurological and Physical Medicine Devices 510(k) Number: K120628
519 J-Oswald Forest, suite 101, Saint-Roch-de-l'Achigan, QC, Canada JOK 3H0 T. 450 588-6555 1 866 650-6555 F. 450 588-0200 www.motioncomposites.com
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