(60 days)
Not Found
No
The description focuses on the mechanical and electrical components of a power wheelchair and does not mention any AI or ML capabilities.
No.
The manufacturer explicitly states, "Sunrise Medical makes no claim as to the therapeutic effectiveness of the product. Sunrise Medical's only claim relates to the ability of the product to provide an optional means of mobility for physically challenged people."
No
Explanation: The device is a power wheelchair designed to provide mobility for physically challenged individuals. Its intended use and description do not involve diagnosing any medical condition or disease.
No
The device description explicitly lists numerous hardware components, including a rigid seat frame, backrest, armrests, cushion, footrests, casters, controller, joystick, motor, brakes, drive wheel, and batteries. This is a physical medical device, not software-only.
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 for physically challenged individuals. This is a mechanical function, not a diagnostic one.
- Device Description: The description details a power wheelchair with components related to mobility (motors, wheels, seating, etc.). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text 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 the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Quickie Interchange FWD w/ Lift Power Wheelchair's intended use is to provide mobility to persons limited to a seating position, that have the capability of operating a powered wheelchair. The Quickie Interchange FWD w/ Lift Power Wheelchair provides an optional means of mobility for physically challenged people.
Product codes
ITI
Device Description
The Quickie Interchange FWD w/ Lift Power Wheelchair is a High End/Mid-Range Rehabilitation type Power Chair Base design that offers the functionality to be used as a Front Wheel drive or a Rear Wheel drive base without changing major frame parts. The system allows for reassembling parts that will for either front or rear wheel drive function. The design will offer a modular approach within the drive base as intve adopt various seating & wiring elements. The device utilizes components typically found on most wheelchairs, including but not limited to rigid seat frame, backrest, product armrests, cushion, footrests and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen taak holders, IV poles, etc. As a motorized wheelchair, it also contains a controller, joystick, motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a powered wheelchair without having to utilize the services of an attendant. Sunrise Medical makes no claim as to the therapeutic effectiveness of the product. Sunrise Medical's only claim relates to the ability of the product to provide an optional means of mobility for physically challenged people.
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)
This device has been tested to appropriate ISO & ANSI/RESNA standards and other applicable requirements passing all test protocols. As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanice and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Quickie Interchange FWD w/ Lift Power Wheelchair was tested in accordance with the ISO EMC Standard "ISO 7176-14:1997. Wheelchairs - Part 14. Power and Control Systems for Electric Wheelchairs - Requirements and Test Methods". The Quickie Interchange FWD v/ Lift Power Wheelchair met the required performance criteria and functioned is intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arrow FWD Power Wheelchair (K991168)
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
Image /page/0/Picture/1 description: The image contains a handwritten string of characters. The string appears to be "K osl3435". The characters are written in a cursive style, and the image is in black and white.
Section 1.0 510(k) Summary
Administrative Information and Device Identification
| Name and address of the manufacturer and
sponsor of the 510(k) submission: | Sunrise Mobility Products Division
2842 Business Park Avenue
Fresno, California 93727-1328 |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer
of the new device: | 2082643 |
| Official contact person for all correspondence: | Joseph E. Olsavsky
Director - Regulatory Affairs
Sunrise Medical
100 DeVilbiss Drive
Somerset, PA 15501
Phone: 814-443-7690
Fax: 814-443-7597
Cell: 814-521-9152
Email: joe.olsavsky@sunmed.com |
| Date Prepared: | November 18, 2004 |
| Device Name: | Quickie Model Powered
Wheelchair |
| Proprietary name of new device: | Quickie Interchange FWD w/ Lift |
| Generic name of the device: | Quickie Powered Wheelchair |
| Classification of the predicate device: | Class II |
| Classification of new device: | Class II |
| Classification Panel: | Physical Medicine |
| Panel Code: | ITI |
| CFR Regulation Number: | 21 CFR 890.3860 |
| Predicate Device Name(s) and 510(k)
number(s): | Arrow FWD Power Wheelchair
(K991168) |
1
Description of Device:
The Quickic Interchange FWD w/ Lift Power Wheelchair is a High End/Mid-Range Rehabilitation type Power Chair Base design that offers the functionality to be used as a Front Wheel drive or a Rear Wheel drive base without changing major frame parts. The system allows for reassembling parts that will for either front or rear wheel drive function. The design will offer a modular approach within the drive base as intve adopt various seating & wiring elements. The device utilizes components typically found on most wheelchairs, including but not limited to rigid seat frame, backrest, product armrests, cushion, footrests and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen taak holders, IV poles, etc. As a motorized wheelchair, it also contains a controller, joystick, motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a powered wheelchair without having to utilize the services of an attendant. Sunrise Medical makes no claim as to the therapeutic effectiveness of the product. Sunrise Medical's only claim relates to the ability of the product to provide an optional means of mobility for physically challenged people.
Comparison of Device Technological Characteristics to Predicate Devices:
This device has similar technological characteristics as the predicate devices. They all use steel and aluminum in their frames and components, and standard foams and covers for the slings, backs and cushions. Microprocessors are typically used with a programmable controller, and the end-user controls the chair by using a joystick or other equivalent command mode. Motors use 24 volt DC rechargeable batteries for an energy source. The operating speeds, maneuverability, power modules, hand controls, seat types, drive wheels, and climbing ability are substantially equivalent and are recommended for indoor and moderate outdoor use. The standard accessories and components are common to all power wheel chair devices.
See Section 8.0.
Statement of Intended Use:
The Quickie Interchange FWD w/ Lift Power Wheelchair's intended use is to provide mobility to persons limited to a seating position, that have the capability of opprating a powered wheelchair. The Quickie Interchange FWD w/ Lift Power Wheelchair provides an optional means of mobility for physically challenged people.
Non-Clinical Testing:
This device has been tested to appropriate ISO & ANSI/RESNA standards and other applicable requirements passing all test protocols.
As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanice and
2
Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Quickic Interchange FWD w/ Lift Power Wheelchair was tested in accordance with the ISO EMC Standard "ISO 7176-14:1997. Wheelchairs - Part 14. Power and Control Systems for Electric Wheelchairs - Requirements and Test Methods". The Quickie Interchange FWD v/ Lift Power Wheelchair met the required performance criteria and functioned is intended.
See Section 10 Test Reports and Attachment A.
Statement of Safety and Effectiveness:
Analysis of comparison of design, function and features of the Sunrise Medical Quickie Interchange FWD w/ Lift Power Wheelchair to the Invacare Arrow FWD Power Wheelchair, together with the results of testing demonstrates the device to be substantially equivalent to the predicate device in terms of meeting performance criteria and functioning as intended.
Conclusion: The Sunrise Medical Quickie Interchange FWD w/ Lift Power Wheelchair is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safety and effectivenss.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joseph E. Olsavsky Director, Regulatory Affairs Sunrise Medical 100 DeVilbiss Drive Somerset, Pennslyvania 15501-2125
Re: K043435
Device Name: Quickie Interchange FWD w/Lift Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: January 28, 2005 Received: January 31, 2005
Dear Mr. Olsavsky
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Mr. Joseph E. Olsavsky
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and your your finding of substantial equivalence of your device to a legally premated 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), please If you desire spocific acrioliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliman
Celia M. Witten, Ph.D., M.D. Director Division Of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K043435
Device Name:
Quickie Interchange FWD w/ Lift Power Wheelchair
Indications for Use:
The Quickie Interchange FWD w/ Lift Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
ﺮ ﺍﻟﻤﺮﺍ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Mellaver
Division of General, Restorative, and Neurological Devices
510(k) Number K043435
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