(176 days)
Not Found
No
The summary describes a purely mechanical wheelchair with no mention of AI, ML, or any computational features.
Yes
The intended use states that the device is "intended to provide mobility to persons restricted to a seated position," which describes a therapeutic function.
No
The device is a mechanical wheelchair intended for mobility, not for diagnosing any medical condition or disease.
No
The device description clearly outlines a physical, mechanical wheelchair with hardware components like wheels, frame, cushion, and footrests. The testing described focuses on the mechanical properties and performance of the physical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons restricted to a seated position." This is a mechanical function for physical support and movement, not for examining specimens from the human body.
- Device Description: The description details the physical characteristics of a wheelchair (folding, wheels, cushion, footrests). It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, and anatomical site, which are often associated with diagnostic devices.
- Performance Studies: The performance studies focus on the mechanical strength, stability, and dimensions of the wheelchair, not on the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is another mechanical wheelchair, not an IVD.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The GEN_3 Mechanical Wheelchair does not perform any such function.
N/A
Intended Use / Indications for Use
The GEN_3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Product codes
IOR
Device Description
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.
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 testing was repeated per ISO standards to those affected by the change in the frame from a rigid to a non-rigid type (folding chair). The retesting was performed to the following standards:
- ISO 7176-1:1999 Wheelchairs – Part 1: Determination of static stability
- ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass and manoeuvring space
- ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8:1998 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
The non-clinical test results demonstrate the modified GEN_2 Wheelchair, called the the GEN_3 Mechanical Mechanical Wheelchair, does not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to the GEN 2, Mechanical Wheelchair previously cleared by FDA.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
Free Wheelchair Mission c/o Sharon Rockwell 5582 Chalon Road Yorba Linda, CA 92886
Re: K141691
Trade/Device Name: GEN 3 Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: November 20, 2014 Received: December 1, 2014
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 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
1
device-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/Resourcesfor You/Industry/default.htm. 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 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 yours,
Felipe Aquel -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141691
Device Name GEN 3 Mechanical Wheelchair
Indications for Use (Describe)
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)
× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image is a logo for the "Free Wheelchair Mission". The logo features two circles, one larger than the other, with a blue fill and black outlines. Below the circles, the text "Free Wheelchair Mission" is written in a bold, sans-serif font. Underneath the mission statement is the phrase "TRANSFORMING LIVES THROUGH THE GIFT OF MOBILITY".
510(K) SUMMARY (21 CFR 807.92)
GEN_3 MECHANICAL WHEELCHAIR
- Free Wheelchair Mission 510(k) Owner: 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: June, 2014
Trade Name: GEN 3 Mechanical Wheelchair
- Common Name: Mechanical Wheelchair
- Classification Name: Mechanical wheelchair per 21 CFR 890.3850, IOR
- Predicate Devices: Free Wheelchair Mission GEN 2 Mechanical Wheelchair. K113713
- The GEN 3 Mechanical Wheelchair is a folding, non-rigid type Device Description: 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 3 Mechanical Wheelchair is intended to provide mobility for persons restricted to a seated position.
The Indications for Use for the GEN 3 are identical to those of the GEN 2 Mechanical Wheelchair.
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Technological Characteristics:
The GEN_3 Mechanical Wheelchair is substantially equivalent in design, materials, and intended use to GEN_2 Mechanical Wheelchair as described in the table below:
| Feature | GEN_2 (predicate) | GEN_3 (modified device) |
|---|---|---|
| Intended Use | To provide mobility to persons | |
| restricted to a seated position. | To provide mobility to persons | |
| restricted to a seated position. | ||
| Frame material | Powder coated steel frame that meets | |
| ASTM A 53/A 53M-2005 and | ||
| JIS G 3444-2004 standards | Powder coated steel frame that meets | |
| ASTM A 53/A 53M-2005 and | ||
| JIS G 3444-2004 standards | ||
| Frame widths | 13.5-19.5" | 14.5-20.5" |
| Overall widths | 29" (medium) | 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 | 36 lbs (with footrests) | 50 lbs (with footrests) |
| Warranty | No warranty | no Warranty |
| Armrests | Fixed in place to serve as armrests | |
| but not to restrict transfers. | Fixed in place to serve as armrests | |
| but not to restrict transfers. | ||
| Front end type | Swing-away | Swing-away |
| Back type | Standard | Standard |
| Footrest | ||
| hangers | Not available | Not available |
| Footplates | Polypropylene, 280 mm adjustable | |
| range with angles adjustable to 0, ± | ||
| 7°, ± 14°, and ± 21°. | Polypropylene, 280 mm adjustable | |
| range with angles adjustable to 0, ± | ||
| 7°, ± 14°, and ± 21°. | ||
| Extension | ||
| tubes | Not available | Not available |
| Back | ||
| upholstery | 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 |
| Feature | GEN_2 (predicate) | GEN_3 (modified device) |
| Anti tips tubes | No | No |
| Standards applied | 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 | Non-rigid (folding) |
| Tubing wall thickness | 0.079" throughout | 0.079" throughout |
| Tube properties | ASTM A 53/A 53M-2005 | |
| JIS G 3444-2004 | ASTM A 53/A 53M-2005 | |
| JIS G 3444-2004 |
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The indications for use for the GEN 3 and the GEN 2 mechanical wheelchairs are identical. The size ranges for the GEN 3 in terms of frame width, seat depth, back depths, chair weight and weight limit overlap those of the GEN 2. The GEN 3 is sold in 4 sizes compared to 3 sizes for the GEN 2. All other features are identical with the exception that the frame for the GEN 3 is nonrigid so the chair can be folded. The brakes are identical for both models. The materials used in the welded tube frame, seat, seat back, fire retardant upholstery, foot plates and wheel locks are also identical between the GEN 3 and the GEN 2. The fundamental technology used in the GEN 3 chairs is identical to that of the GEN 2. The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the static, impact and fatigue strengths. Any differences in features to the predicate do not affect the performance of the device and do not raise new types of safety or effectiveness questions.
| Non-Clinical
Performance Data: | Non-clinical testing was repeated per ISO standards to those
affected by the change in the frame from a rigid to a non-rigid type
(folding chair). The retesting was performed to the following
standards: |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1) ISO 7176-1:1999 Wheelchairs – Part 1: Determination of static
stability
2) ISO 7176-5:2008 Wheelchairs – Part 5: Determination of
dimensions, mass and manoeuvring space
3) ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of
seating and wheel dimensions
4) ISO 7176-8:1998 Wheelchairs - Part 8: Requirements and test
methods for static, impact and fatigue strengths |
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Conclusions: The non-clinical test results demonstrate the modified GEN_2 Wheelchair, called the the GEN_3 Mechanical Mechanical Wheelchair, does not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to the GEN 2, Mechanical Wheelchair previously cleared by FDA.