(196 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair. There is no mention of AI, ML, or any computational processing of data for decision-making or control.
No.
The device is a manual wheelchair intended for mobility, not to treat or cure a medical condition.
No
The Convaid Flyer is a manual wheelchair providing mobility, not diagnosing medical conditions. Its purpose is to assist individuals with disabilities in movement, not to identify or monitor diseases or conditions.
No
The device description clearly outlines a physical, mechanical device (manual wheelchair) with components like wheels, frame, seating module, and various accessories. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons with disabilities who are non-ambulatory. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is a manual wheelchair with components like wheels, frame, seating, and positioning accessories. These are mechanical and structural components, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnostic purposes (identifying diseases, conditions, or predispositions)
- Use of reagents or specialized laboratory equipment
The device is clearly described as a mobility aid, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Convaid Flyer models are manual wheelchairs; they are intended to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Flyer Transit models FL12T, FL13T, FL14T, FL15T and FL16T comply with the requirements of RESNA WC4:2012 section 19 Wheelchairs used as seating in motor vehicles.
Product codes
IOR, LBE
Device Description
The Flyer series are attendant propelled manual wheelchairs constructed of the same materials and contain the same typical components and accessories found on most manual attendant propelled wheelchairs. The product consists of high strength powder coated tubular aluminum and steel plates that are welded, brazed, riveted or bolted. It comes standard with 5.5' front wheels attached to pivoting casters for steering and turning and 11.5" wheels in the rear. The product has a lightweight rigid base with a folding removable seating module, which is designed for everyday indoor or outdoor use on flat firm terrain. The Flyer offers its users a -5° to 40° range of continuously adjustable tilt-in-space achieved through the use of a single mechlok and hand lever to control the tilt action and 80° to 170°of seat to back adjustment (recline) that is controlled with a hand activated two plunger type pin system and plates on each side of the seating module with 10° incrementally located holes, the plungers pins engage to maintain the desired degree of recline. The chair comes standard with seat and back cushions that meet the requirements of WC1 section 16 for flammability and ISO 10993 biological evaluation of medical devices. However, the user also has the option of using a commercially available compatible seat and back cushion. The seat depth is set at the factory to one of four (4) depths and an adjustable back height of 17 to 23 inches. Positioning accessories include a two point belt or three point belt with crotch pad, foot positioners, H-harness with padded covers, adjustable footplate, head support and adjustable headwing, flip-up armrests and LTV bracket. The Flyer Transit models are WC4:2012 section 19 transit approved for use as a seating in motor vehicles.
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
The end user of the Flyer models as with all Convaid attendant propelled wheelchair products is not determined by age but by body dimensions and mass, as such it is foreseeable that a person could include children and adults of all ages that may have a Convaid Flyer wheelchair recommended by a healthcare professional.
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 Testing:
- RESNA WC-1:2009 Section 1 Determination of static stability
- RESNA WC-1:2009 Section 5 Determination of dimensions, mass and maneuvering space
- RESNA WC-1:2009 Section 7 Method of measurement of seating and wheel dimensions
- RESNA WC-1:2009 Section 8 - Requirements and test methods for static, impact and fatigue strengths
- RESNA WC-1:2009 Section 11 - Test dummies
- RESNA WC-1:2009 Section 13 Determination of coefficient of friction of test surfaces
- RESNA WC-1:2009 Section 15 - Requirements for information disclosure, documentation and labeling
- RESNA WC-1:2009 Section 16 - Resistance to ignition of upholstered parts - Requirements and test methods
- RESNA WC-2:2009 Section 3 - Determination of effectiveness of brakes
- RESNA WC-4:2012 Section 19 Wheelchairs used as seats in motor vehicles
- ISO 10993-5:2009 Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Tests for irritation and skin sensitization
Key Results: Because the requirements have been met for the above listed standards and the performance tests for the Flyer series and Trekker series yielded similar results we have determined that there are no new risks to the safety or effectiveness of the device and it is therefore substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
October 18, 2017
Convaid Products Inc. % Donald Griggs Quality Assurance Manager Convaid Products 11c. 2830 California St Torrance, California 90503
Re: K171017
Trade/Device Name: Convaid Flyer FL12, FL13, FL14, FL15 and FL16 Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR, LBE Dated: August 22, 2017 Received: September 19, 2017
Dear Donald Griggs:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE) 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 (DICE) 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) K171017
Device Name
Convaid Products Flyer Series Manual Wheelchairs Convaid Flyer FL12, FL13, FL14, FL15 and FL16 Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
Indications for Use (Describe)
The Convaid Flyer models are manual wheelchairs; they are intended to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Flyer Transit models FL12T. FL14T. FL15T and FL16T comply with the requirements of RESNA WC4:2012 section 19 Wheelchairs used as seating in motor vehicles.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo and contact information for Convaid. The logo features a blue graphic element next to the company name, "Convaid," in a bold, sans-serif font. Below the logo, the address is listed as 2830 California Street, Torrance, CA 90503, along with the phone number 888-CONVAID 310/618-0111 and website www.convaid.com.
Convaid Product Inc. Model: FLYER Manual Wheelchair K171017 510(k) Summary of Safety and Efficacy Revised 10/17/2017
A. General Information
| Submitter Name | Convaid Products LLC. |
|---|---|
| Address | 2830 California Street Torrance, CA |
| 90503 | |
| Phone | (310) 618-0111 |
| Fax | (310) 618-2172 |
| Contact Person | Don Griggs, |
| Quality Assurance Manager | |
| Registration Number | 2022883 |
| Date Prepared | 08/28/2017 |
B. Device
| Device Trade Name | Flyer | FL12, FL13, FL14,
FL15, FL16 |
|-----------------------|-------------------|-----------------------------------------|
| | Flyer Transit | FL12T, FL13T,
FL14T, FL15T,
FL16T |
| Common/Generic Name | Wheelchair-Manual | |
| Registration Number | 2022883 | |
| Product Code | IOR, LBE | |
| Device Classification | Class 1 | |
| Regulatory Number | 890.3850 | |
Identification of Legally Marketed Devices ﻥ
| Manufacture Name | Convaid Products LLC. |
|---|---|
| Product Name | Convaid Trekker |
| 510K Number | K140416 |
| Date Cleared | 09/17/2014 |
4
Image /page/4/Picture/0 description: The image shows the logo for Convaid, a company that provides mobility solutions. The logo features a blue wave-like design element on the left, followed by the company name "Convaid" in a bold, sans-serif font. Below the logo, the address "2830 California Street Torrance, CA 90503" and the phone number "888-CONVAID 310/ 618-0111" are printed.
D. Indication of use
The Convaid Flyer models are manual wheelchairs; they are intended to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Flyer Transit models FL12T, FL13T, FL14T, FL15T and FL16T comply with the requirements of RESNA WC4:2012 section 19 Wheelchairs used as seating in motor vehicles.
E. Intended Use
Convaid's Flyer series are a lightweight ridge high strength aluminum and steel wheelchair base with a removable mobility seating system for everyday indoor and outdoor use on flat firm terrain. These persons typically have some form of neuromuscular disorder that limits their ability to self-propel such as Cerebral Palsy.
The end user of the Flyer models as with all Convaid attendant propelled wheelchair products is not determined by age but by body dimensions and mass, as such it is foreseeable that a person could include children and adults of all ages that may have a Convaid Flyer wheelchair recommended by a healthcare professional.
A risk analysis is performed on all Convaid products to evaluate the device including the possibility of children and or other impaired population groups to mitigate any safety issues as much as possible through design and labeling. Warnings and cautions are placed throughout the user's guide to alert caregivers.
F. Device Description
The Flyer series are attendant propelled manual wheelchairs constructed of the same materials and contain the same typical components and accessories found on most manual attendant propelled wheelchairs. The product consists of high strength powder coated tubular aluminum and steel plates that are welded, brazed, riveted or bolted. It comes standard with 5.5' front wheels attached to pivoting casters for steering and turning and 11.5" wheels in the rear. The product has a lightweight rigid base with a folding removable seating module, which is designed for everyday indoor or outdoor use on flat firm terrain. The Flyer offers its users a -5° to 40° range of continuously adjustable tilt-in-space achieved through the use of a single mechlok and hand lever to control the tilt action and 80° to 170°of seat to back adjustment (recline) that is controlled with a hand activated two plunger type pin system and plates on each side of the seating module with 10° incrementally located holes, the plungers pins engage to maintain the desired degree of recline. The chair comes standard with seat and back cushions that meet the requirements of WC1 section 16 for flammability and ISO 10993 biological evaluation of medical devices. However, the user also has the option of using a commercially available compatible seat and back cushion. The seat depth is set at the factory to one of four (4) depths and an adjustable back height of 17 to 23 inches. Positioning accessories include a two point belt or three point belt with crotch pad, foot positioners, H-harness with padded covers, adjustable footplate, head support and adjustable headwing, flip-up armrests and LTV bracket. The Flyer Transit models are WC4:2012 section 19 transit approved for use as a seating in motor vehicles.
5
Image /page/5/Picture/0 description: The image shows the logo for Convaid, along with their address, phone number, and website. The address is 2830 California Street Torrance, CA 90503. The phone number is 888-CONVAID 310/618-0111, and the website is www.convaid.com.
Comparison of Device Characteristics to Predicate G.
The Convaid Flyer has similar characteristics, accessories and technology and is constructed using identical materials as the predicate device, the Convaid Trekker cleared on 09/17/2014 K140416 (see comparison table below). Both are attendant propelled manual wheelchairs with similar operating characteristics and maneuverability and are recommended for indoor or outdoor use on flat firm terrain.
The Convaid Flyer has a ridge base frame and a removable seating module while the Trekker has a non-ridge base frame and removable seating module. Both systems attach to their bases using the same locking mechanism and allow for easy storage and transport. The Trekker's seating module can be placed on the base facing in either forward or rear configurations while the Flyer is only forward facing. The weight capacity variance is due to the Flyer having a ridge base allowing for a maximum weight capacity of 170lbs and the Trekker using a non-ridge/folding frame with a maximum weight capacity of 110 lbs.
The Flyer is available with seat widths from 12 to 16 inches in 1 inch increments, while the Trekker is available in a 12" or 14" inch seat width. The Flyer also allows for the adjustment of the chair width when using an optional growth kit from 12 inches up to 16 inches maximum in 1 inch increments. The growth feature is an available feature on other manufactures wheelchairs to allow for the changes in user mass and dimensions and as such poses no new risks.
The Convaid Flyer and the Convaid Trekker were subjected to the same RESNA wheelchair tests: WC1 section 1 static stability, section 8 static, impact and fatigue strengths, and section 16 resistance to ignition and WC2 section 3 determination of effectiveness of brakes as well as non- pass/fail requirements of Sections 5. 7. 11. 13 as referenced below in section H. The use of approved standards allows for the comparison of products that by virtue of completing and passing the same test requirements establishes a basis of functional comparability of the these two products.
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for Convaid. The logo features a blue graphic element next to the company name, "Convaid," in a bold, sans-serif font. Below the logo is the address "2830 California Street Torrance, CA 90503," followed by the phone numbers "888-CONVAID 310/618-0111" and the website address "www.convaid.com."
| | FL12
to
FL16 | FL12T
to
FL16T | TR12
TR12T | TR14
TR14T |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Seat width | 12" to 16" | 12" to 16" | 12 " | 14" |
| Seat depth
"dependent of seat
depth position 1 to4" | 15.5" to
25.5" | 15.5" to
25.5" | 6" to 12" | 9" to 16" |
| Growth option
(Width) | Yes | Yes | No | No |
| Seat to back height | 17" to 23" | 17" to 23" | 15" to 21" | 17" to 26" |
| Seat to footrest | 5.8" to 11" | 5.8" to 11" | 6" to 14" | 6" to 14" |
| Footplate 1 piece
adjustable | +/- 15° | +/- 15° | +/- 15° | +/- 15° |
| Footplate individual
angle
Adjustable | Unlimited
angle
adjustment | Unlimited angle
adjustment | No | No |
| Seat to floor | 15" | 15" | 16" – 25" | 17" – 25" |
| Seat to back
angle/recline | 80° to 170° | 80° to 170° | 80° to 170° | 80° to 170° |
| Tilt-in-space
adjustment | -5° to 40° | -5° to 40° | -5° to 45° | -5° to 45° |
| Headrest extension | 8" | 8" | 6" | 6" |
| Chair weight | 29.2 lbs. | 29.2 lbs. | 32 lbs. | 33 lbs. |
| Chair width | 21" to 25" | 21" to 25" | 24.3" | 26.3" |
| Overall height | 40" | 40" | 37.5" | 37.5" |
| Overall length | 25.75" | 25.75" | 42" | 42" |
| Weight capacity | 85 lbs
Position 1
or
170lbs for
2 thru 4 | 85 lbs
Position 1
or
170lbs for 2 thru 4 | 75 lbs.
Std.
or transit | 110 lbs.
Std.
or transit |
| Tilt in space | Single
mech. lock | Single mech. lock | Single
mech. lock | Single mech. lock |
| Removable seating
module with seat and
back cushions | Yes | Yes | Yes | Yes |
| | FL12
To
FL16 | FL12T
To
FL16T | TR 12
and
TR14 | TR12T
and
TR14T |
| Transit Option | No | Yes | No | Yes |
| Frame tubular
6061 Aluminum | Yes | Yes | Yes | Yes |
| Upholstery and
fabric accessories | Same | Same | Same | Same |
| Armrest option
Are optional on both. *Note item added
to Trekker after release | Yes | Yes | *Yes | *Yes |
| Wheel locks | Foot
actuated | Foot
actuated | Foot
actuated | Foot
actuated |
| Frame coating | Powder
coated | Powder
coated | Powder
coated | Powder
coated |
| Camber | N/A | N/A | N/A | N/A |
| Front caster diameter | 6"
or
7.5" | 6"
or
7.5" | 6"
or
7.5" | 6"
or
7.5 |
| Rear wheel diameter | 11.5"
or 16" | 11.5"
or 16" | 11.5" | 11.5" |
| Patient contacting surfaces
Skin Contact duration category A