(18 days)
P200, P120
No
The document describes a standard powered wheelchair with a controller, motors, and batteries. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a powered wheelchair that provides mobility for individuals with physical challenges. While it aids in daily living and can prevent secondary complications from immobility, it does not directly treat or diagnose a disease or condition in a therapeutic manner according to the provided information.
No
The device is a powered wheelchair intended to provide mobility for physically challenged persons, not to diagnose medical conditions.
No
The device description clearly outlines numerous hardware components including a frame, seat, armrests, footrest, cushion, casters, drive wheels, controllers, joysticks, motors, brakes, and batteries. The performance studies also focus on hardware-related standards and tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility for physically challenged persons. This is a mechanical function, not a diagnostic test performed on biological samples.
- Device Description: The device is a powered wheelchair with components like a frame, seat, motors, and controllers. These are all related to mobility and transportation, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and mechanical aspects of the wheelchair (stability, braking, fatigue strength, etc.), not on the accuracy or reliability of a diagnostic test.
In summary, the device is a medical device designed for mobility assistance, not for performing diagnostic tests outside of the body.
N/A
Intended Use / Indications for Use
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic, Quadriplegic, Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions And other immobilizing or debilitating conditions.
Product codes
ITI
Device Description
The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller. The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. Aesthetics have been improved by adding a plastic thermoformed molded cover.
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
all ages
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)
This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include: Static Stability (Pass), Dynamic Stability (Pass), Effectiveness of Brakes (Pass), Energy consumption (Pass), Overall Dimensions (Pass), Maximum Speed acceleration and retardation (Pass), Static Impact (Pass), Fatigue Strength (Pass), Climatic Test (Pass), Obstacle Climbing Ability (Pass), Testing of Power and Control System (Pass), EMC Testing (Pass).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Quickie P200 by Sunrise Medical, Quickie P120 by Sunrise Medical
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
6 1998 NOV
CONFIDENTIAL
983677
13.0 510(k) SUMMARY OF SAFETY AND EFFICACY
Submitter: Sunrise Medical (303) 218-4500 Mobility Products Division 7477 East Dry Creek Parkway Longmont, CO 80503
Rebecca Andersen October 13, 1998 Date:
Name(s) of the device(s): Identification of predicate device(s): 1) Quickie P200 by Sunrise Medical
- Quickie P120 by Sunrise Medical
G-424 Power wheelchair Modification to a Sunrise Device
Description of the device:
The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller.
The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries
Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding a plastic thermoformed molded cover.
Intended use:
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as :
| Arthritis | Tetraplegic |
|---|---|
| Amputee | Quadriplegic |
| Paraplegic | Spina Bifida |
| Cerebral Palsy | Head Injury or Trauma |
| Hemiplegic | Muscular Dystrophy |
Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating conditions
Comparison of device characteristics to predicate(s):
The proposed device modifications combine technological characteristics from two Sunrise predicate devices.
Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding plastic thermoformed molding covers.
1
Testing:
This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include:
| Static Stability | Pass |
|---|---|
| Dynamic Stability | Pass |
| Effectiveness of Brakes | Pass |
| Energy consumption | Pass |
| Overall Dimensions | Pass |
| Maximum Speed acceleration and retardation | Pass |
| Static Impact | Pass |
| Fatigue Strength | Pass |
| Climatic Test | Pass |
| Obstacle Climbing Ability | Pass |
| Testing of Power and Control System | Pass |
| EMC Testing | Pass |
Safety:
The Quickie G-424 Power Wheelchair is substantially equivalent to the existing Sunrise Medical predicate devices. The modifications to this device have been validated using appropriate Design Controls and therefore have been demonstrated to be "non significant" with respect to safety or effectivenes.
i
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.
6 1998 NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. Mobility Products Division 7477 East Dry Creek Parkway Longmont, Colorado 80503
K983677 Re: G-424 Power Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: October 13, 1998 Received: October 19, 1998
Dear Ms. Andersen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Rebecca Andersen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility
This includes conditions in all ages such as:
| Arthritis | Head Injury or Trauma |
|---|---|
| Amputee | Muscular Dystrophy |
| Paraplegic | Multiple Sclerosis |
| Cerebral Palsy | Polio |
| Hemiplegic | Geriatric Conditions |
| Tetraplegic (Quadraplegic) | And other immobilizing or debilitating conditions |
| Spina Bifida |
A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249
510(k) number: Not assigned as of this time
Device name: G-424
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR801.109) 0
0 Over-the-counter use
fcoello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ___K983677
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