K Number
K113713
Device Name
GEN_2 MECHANICAL WHEELCHAIR
Date Cleared
2012-05-07

(140 days)

Product Code
Regulation Number
890.3850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Device Description
The GEN 2 mechanical wheelchair is a highly adaptable all-purpose 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.
More Information

Not Found

No
The summary describes a standard mechanical wheelchair with adjustable features and references non-clinical testing based on ISO standards for mechanical properties, with no mention of AI or ML.

No
The device is a mechanical wheelchair intended for mobility, not for treating or curing a disease or condition.

No

The device description clearly states its purpose is to provide mobility. The "Intended Use / Indications for Use" section indicates it is a mobility aid for persons restricted to a seated position, not for diagnosing any medical condition.

No

The device description and performance studies clearly indicate this is a physical mechanical wheelchair with hardware components, not a software-only device.

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 physical function, not a diagnostic test performed on samples from the human body.
  • Device Description: The description details a mechanical device for mobility, not equipment used to examine specimens.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.
  • Performance Studies: The performance studies focus on mechanical standards and safety for a wheelchair, not the accuracy or reliability of a diagnostic test.

This device is clearly a mechanical mobility aid, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

Product codes (comma separated list FDA assigned to the subject device)

IOR

Device Description

The GEN 2 mechanical wheelchair is a highly adaptable all-purpose 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_2 is a manually operated device intended to provide mobility for persons restricted to a sitting position.

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 has been performed to mechanical wheelchair international standards including:

  1. ISO 7176-1:1999 Determination of static stability
  2. ISO 7176-3:2006 Determination of effectiveness of breaks
  3. ISO 7176-5:2008 Determination of dimensions, mass and manoeuvring space
  4. ISO 7176-7:1998 Measurement of seating and wheel dimensions
  5. ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue
  6. ISO 7176-15:1996 Requirements for information disclosure, documentation and labeling
  7. ISO 7176-16: 1997 Resistance to ignition of upholstered parts --Requirements and test methods

The ISO tests were conducted with methods that met the following standards:

  1. ISO 7176-11:1992 Test dummies
  2. ISO 7176-13: 1989 Determination of coefficient of friction of test surfaces

The non-clinical test results demonstrate the GEN 2 Mechanical Wheelchair does not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA.

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.

Ki Mobility Catalyst Wheelchair, K062660

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/0 description: The image shows the logo for the "Free Wheelchair Mission". The logo consists of a drawing of two wheels, one larger than the other, with the words "Free Wheelchair Mission" written below. Underneath the name is the text "TRANSFORMING LIVES THROUGH THE GIFT OF MOBILITY".

KII3713 PAGE 1 OF 4

MAY - 7 2012

510(K) SUMMARY (21 CFR 807.92)

GEN 2 MECHANICAL WHEELCHAIR

Free Wheelchair Mission 510(k) Owner: 15279 Alton Parkway, Suite 300 Irvine, CA 92618 Tel: 949-273-0858 Fax: 949-273-8471

Contact Person: Sharon Rockwell Tel: 714-695-9269 E-mail: srockwell@writeme.com

December, 2011 Date Prepared:

GEN 2 Mechanical Wheelchair Trade Name:

Mechanical Wheelchair Common Name:

Classification Name: Mechanical wheelchair per 21 CFR 890.3850, IOR

Ki Mobility Catalyst Wheelchair, K062660 Predicate Devices:

The GEN 2 mechanical wheelchair is a highly adaptable all-Device Description: purpose 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_2 is a manually operated device intended to provide Intended Use: mobility for persons restricted to a sitting position.

The Indications for Use are identical to those of the predicate devices.

1

Technological Characteristics:

Technological Characteristics: The GEN_2 mechanical wheelchair is substantially equivalent in design, materials, and intended use to the Ki Mobility Catalyst mechanical wheelchair as described in the table below:

FeatureCatalystGEN 2
Intended UseAs a means of mobility for
persons restricted to a sitting
position.To provide mobility to persons
restricted to a seated position.
Frame material6061-T6 AluminumPowder coated steel frame that
meets ASTM A 53/A 53M-2005
and JIS G 3444-2004 standards
Frame widths14-20"13.5-19.5"
Overall widths20.5-26.5"29"
Seat depths14-20"11.5-17"
Back heights8.5-19"11.8-19"
Weight limit220 lbs220 lbs
Chair weight23 lbs (without footrests)36 lbs (with footrests)
ArmrestsFlip back height adjustable desk
and full length arm pads.
Tubular swing-away.Fixed in place to serve as
armrests but not to restrict
transfers.
Front end typeSwing-away, non-swing-awaySwing-away
Back typeStandardStandard
Footrest hangers70°, elevating leg restNA
FootplatesComposite, foam, angle
adjustablePolypropylene, 280 mm
adjustable range with angles
adjustable to 0, ± 7°, ± 14°, and ±
21°.
Extension tubesExtra short, short, med, longNA
Back upholsteryLow, med, tall, adjustableAdjustable to 4 different heights
Axle platesStandard, curved, amputee,
offsetNA
Wheel sizes22, 24, 2626"
Wheel typesSpoke, composite mag, Octopus
(performance spoke)Spoke
Tire typesPneumatic, full profile
polyurethane, iron cap
(puncture resistant), high
pressurePneumatic
HandrimsAluminum, plastic coated
projectionsPowder coated steel
FeatureCatalystGEN 2
Caster sizes4, 5, 6, 8"8"
Caster typesPoly, pneumatic, pneumatic
with airless insertPolypropylene
Forks sizes4, 5, 6, 7" frog legs5"
Wheel locksPush to lock, pull to lock, low
profilePull to lock
Anti tips tubesYesNo
Standards appliedStatic Stability and Fatigue
Strength, ANSI/RESNA std
sections 1, 5, 7, 8, 16 and 93ISO 7176-1, 3, 5, 7, 8, 15, 16
Tubing wall thickness0.070" on frame except front
vertical tube which is 0.1". X-
tube is 0.070"0.079" throughout
Tube properties6061-T4 prior to welding.
After welding, the component is
treated up to T-6.ASTM A 53/A 53M-2005
JIS G 3444-2004

2

The indications for use for the GEN 2 and the predicate device are identical. The size ranges in terms of frame width, seat depth, back depths, chair weight and weight limit overlap those of the predicate device. Most other features are very similar. The fundamental technology, welded tube frame, fire retardant upholstery, and wheel locks are the same. The information provided supports a substantial equivalence decision. 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
    Non-clinical testing has been performed to mechanical wheelchair Performance Data: international standards including:
  1. ISO 7176-1:1999 Determination of static stability

  2. ISO 7176-3:2006 Determination of effectiveness of breaks

  3. ISO 7176-5:2008 Determination of dimensions, mass and manoeuvring space

  4. ISO 7176-7:1998 Measurement of seating and wheel dimensions

  5. ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue

  6. ISO 7176-15:1996 Requirements for information disclosure, documentation and labeling

  7. ISO 7176-16: 1997 Resistance to ignition of upholstered parts --Requirements and test methods

3

The ISO tests were conducted with methods that met the following standards:

  1. ISO 7176-11:1992 Test dummies

  2. ISO 7176-13: 1989 Determination of coefficient of friction of test surfaces

The non-clinical test results demonstrate the GEN 2 Mechanical Conclusions: Wheelchair does not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA.

4

Image /page/4/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Free Wheelchair Mission % Ms. Sharon Rockwell Consultant 5582 Chalon Road Yorba Linda, California 92886

MAY - 7 2012

、Re: K113713

Trade/Device Name: Free Wheelchair Mission GEN 2 Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 26, 2012 Received: March 27, 2012

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 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.

5

Page 2 - Ms. Sharon Rockwell

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Eunel Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Free Wheelchair Mission GEN_2 Mechanical Wheelchair

Indications for Use:

The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (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)

signature
Division Sign-Off

Page ( of )

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113713