(16 days)
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
This document is a 510(k) premarket notification for mechanical wheelchairs (GEN 2 and GEN 3 models). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on an AI/ML powered device.
Therefore, many of the requested elements (acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC comparative effectiveness, standalone performance, etc.) are not applicable or not provided in this document.
However, I can extract information related to the performance testing conducted for these mechanical wheelchairs.
Acceptance Criteria and Reported Device Performance
The document describes non-clinical testing performed to establish the safety and effectiveness of the modified GEN 2 and GEN 3 mechanical wheelchairs. The specific acceptance criteria are implied by adherence to the ISO 7176-1:2014 standard for static stability.
| Acceptance Criteria (Implied by standard) | Reported Device Performance (Implied by conclusion) |
|---|---|
| Compliance with ISO 7176-1:2014 for static stability. | Retesting was performed in accordance with ISO 7176-1:2014 (forward, rearward, and lateral static stability tests). |
| Device modifications do not affect performance. | The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing... The modification does not affect the performance of the devices. |
| Device modifications do not raise new safety/effectiveness questions. | Non-clinical test results demonstrate the modified GEN 2 and GEN 3 Mechanical Wheelchairs do not raise any issues regarding safety and effectiveness. |
Note: The document explicitly states "The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the forward, rearward and lateral static stability tests performed in accordance with ISO 7176-1:2014." This implies that the devices met the requirements of this standard.
The other questions are not relevant to this document as it pertains to physical medical devices (mechanical wheelchairs) and not an AI/ML powered device.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Free Wheelchair Mission % Sharon Rockwell Consultant Sharon Rockwell, Consultant 5582 Chalon Road Yorba Linda, California 92886
Re: K170701
Trade/Device Name: Gen 2, Gen 3 Mechanical Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 1, 2017 Received: March 8, 2017
Dear Ms. Rockwell:
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
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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 devicerelated 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 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
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Indications for Use
510(k) Number (if known) K170701
Device Name GEN_2 and GEN_3 Mechanical Wheelchairs
Indications for Use (Describe)
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated 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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Image /page/3/Picture/0 description: The image contains the words "FREE WHEELCHAIR MISSION" in bold, dark blue font. To the right of the text is a stylized logo of a person in a wheelchair. The logo is made up of overlapping circles and rectangles in shades of blue, green, purple, and gray.
510(K) SUMMARY (21 CFR 807.92)
FREE WHEELCHAIR MISSION MECHANICAL WHEELCHAIRS
| 510(k) Owner: | Free Wheelchair Mission |
|---|---|
| 15279 Alton Parkway, Suite 300 | |
| Irvine, CA 92618 | |
| Tel: 949-273-0858 | |
| Fax: 949-273-8471 |
- Sharon Rockwell Contact Person: Tel: 714-695-9269 E-mail: srockwell(@writeme.com
- Date Prepared: March, 2017
- GEN 2 and GEN 3 Mechanical Wheelchairs Trade Name:
- Common Name: Mechanical Wheelchair
- Classification Name: Mechanical wheelchair per 21 CFR 890.3850, IOR
- Predicate Devices: Free Wheelchair Mission GEN 2 Mechanical Wheelchair. K113713 and GEN 3 Mechanical Wheelchair, K141691
- Device Description: The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
- Indication for Use: The GEN 2 Mechanical Wheelchair is intended to provide mobility for persons restricted to a sitting position.
The GEN 3 Mechanical Wheelchair intended to provide mobility for persons restricted to a sitting position.
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The Indications for Use of the modified devices are identical to those of the predicate devices.
Technological
Characteristics: The modified GEN_2 and GEN_3 Mechanical Wheelchairs are substantially equivalent in design, materials, and intended use to the predicate GEN 2 and GEN 3 Mechanical Wheelchairs. The modification to the Free Wheelchair Mission Mechanical Wheelchairs is a repositioning of the axle to reduce the weight burden on the castor wheels, reducing the downward force required by the attendant to move the castors off the ground to go over a step or curb. The tables below indicate there are no changes to the technological characteristics of the wheelchairs.
| Feature | GEN 2 (predicate) | GEN 2 (modified device) |
|---|---|---|
| Intended Use | To provide mobility to personsrestricted to a seated position. | To provide mobility to personsrestricted to a seated position. |
| Frame material | Powder coated steel frame that meetsASTM A 53/A 53M-2005 andJIS G 3444-2004 standards | Powder coated steel frame that meetsASTM A 53/A 53M-2005 andJIS G 3444-2004 standards |
| Frame widths | 13.5-19.5" | 13.5-19.5" |
| Overall widths | 29" (medium) | 29" (medium) |
| Seat depths | 11.5-17" | 11.5-17" |
| Back heights | 11.8-19" | 11.8-19" |
| Weight limit | 220 lbs | 220 lbs |
| Chair weight | 36 lbs (with footrests) | 36 lbs (with footrests) |
| Warranty | No warranty | No warranty |
| Armrests | Fixed in place to serve as armrestsbut not to restrict transfers. | Fixed in place to serve as armrestsbut not to restrict transfers. |
| Front end type | Swing-away | Swing-away |
| Back type | Standard | Standard |
| Footresthangers | Not available | Not available |
| Footplates | Polypropylene, 280 mm adjustablerange with angles adjustable to 0, ±7°, ± 14°, and ± 21°. | Polypropylene, 280 mm adjustablerange with angles adjustable to 0, ±7°, ± 14°, and ± 21°. |
| Extensiontubes | Not available | Not available |
| Backupholstery | Adjustable to 4 different heights | Adjustable to 4 different heights |
| Axle plates | Not available | Not available |
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| Feature | GEN_2 (predicate) | GEN_2 (modified device) |
|---|---|---|
| Wheel sizes | 26" | 26" |
| Wheel types | Spoke | Spoke |
| Tire types | Pneumatic | Pneumatic |
| Handrims | Powder coated steel | Powder coated steel |
| Caster sizes | 8" | 8" |
| Caster types | Rubber | Rubber |
| Forks sizes | 5" | 5" |
| Wheel locks | Pull to lock | Pull to lock |
| Anti tips tubes | No | No |
| Standardsapplied | ISO 7176-1, 3, 5, 7, 8, 11, 13, 15, 16 | ISO 7176-1, 3, 5, 7, 8, 11, 13, 15, 16 |
| Frame style | Rigid | Rigid |
| Tubing wallthickness | 0.079" throughout | 0.079" throughout |
| Tubeproperties | ASTM A 53/A 53M-2005JIS G 3444-2004 | ASTM A 53/A 53M-2005JIS G 3444-2004 |
| Feature | GEN_3 (predicate) | GEN_3 (modified device) |
|---|---|---|
| Intended Use | To provide mobility to personsrestricted to a seated position. | To provide mobility to personsrestricted to a seated position. |
| Frame material | Powder coated steel frame that meetsASTM A 53/A 53M-2005 andJIS G 3444-2004 standards | Powder coated steel frame that meetsASTM A 53/A 53M-2005 andJIS G 3444-2004 standards |
| Frame widths | 14.5-20.5" | 14.5-20.5" |
| Overall widths | 25.6-31.5" | 25.6-31.5" |
| Seat depths | 11.5-17" | 11.5-17" |
| Back heights | 11.8-19" | 11.8-19" |
| Weight limit | 220 lbs | 220 lbs |
| Chair weight | 50 lbs (with footrests) | 50 lbs (with footrests) |
| Warranty | no Warranty | no Warranty |
| Armrests | Fixed in place to serve as armrestsbut not to restrict transfers. | Fixed in place to serve as armrestsbut not to restrict transfers. |
| Front end type | Swing-away | Swing-away |
| Back type | Standard | Standard |
| Footresthangers | Not available | Not available |
| Footplates | Polypropylene, 280 mm adjustablerange with angles adjustable to 0 + | Polypropylene, 280 mm adjustablerange with angles adjustable to 0 + |
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| Feature | GEN_3 (predicate) | GEN_3 (modified device) |
|---|---|---|
| 7°, ± 14°, and ± 21°. | 7°, ± 14°, and ± 21°. | |
| Extensiontubes | Not available | Not available |
| Backupholstery | Adjustable to 4 different heights | Adjustable to 4 different heights |
| Axle plates | Not available | Not available |
| Wheel sizes | 26" | 26" |
| Wheel types | Spoke | Spoke |
| Tire types | Pneumatic | Pneumatic |
| Handrims | Powder coated steel | Powder coated steel |
| Caster sizes | 8" | 8" |
| Caster types | Rubber | Rubber |
| Forks sizes | 5" | 5" |
| Wheel locks | Pull to lock | Pull to lock |
| Anti tips tubes | No | No |
| Standardsapplied | ISO 7176-1, 3, 5, 7, 8, 11, 13, 15, 16 | ISO 7176-1, 3, 5, 7, 8, 11, 13, 15, 16 |
| Frame style | Non-rigid (folding) | Non-rigid (folding) |
| Tubing wallthickness | 0.079" throughout | 0.079" throughout |
| Tubeproperties | ASTM A 53/A 53M-2005JIS G 3444-2004 | ASTM A 53/A 53M-2005JIS G 3444-2004 |
The indications for use for the modified GEN 2 and GEN 3 Mechanical Wheelchairs are unchanged. The fundamental technology used in the GEN 2 and GEN 3 chairs is unchanged from the predicate devices. The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the forward, rearward and lateral static stability tests performed in accordance with ISO 7176-1:2014. The modification does not affect the performance of the devices and does not raise new types of safety or effectiveness questions.
| Non-Clinical | |
|---|---|
| Performance Data: | Non-clinical testing was repeated per ISO standards to those testsaffected by the repositioning of the axle. The retesting wasperformed to the following standards: |
| 1) ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static |
-
- ISO 7176-1:2014 Wheelchairs Part 1: Determination of static stability
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Conclusions: The non-clinical test results demonstrate the modified GEN 2 and GEN_3 Mechanical Wheelchairs do not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to to the Free Wheelchair Mission Mechanical Wheelchairs previously cleared by FDA.
§ 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).