(11 days)
Not Found
No
The device description and intended use clearly state it is a manually operated mechanical wheelchair with typical components, and there is no mention of AI, ML, or related technologies.
No
The device is described as a wheelchair intended to enhance mobility for physically challenged individuals, not to treat or cure a disease or condition. It focuses on providing support and mobility rather than therapeutic intervention.
No
The device is described as a "mobile positioning system" and a "manually operated mechanical wheelchair" intended to "enhance mobility to physically challenged persons." There is no indication that it is used to diagnose any medical condition.
No
The device description explicitly states it is a "manually operated mechanical wheelchair" consisting of physical components like a frame, wheels, and upholstery. This indicates it is a hardware device, not software-only.
Based on the provided information, the AIDC 8500-II Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to physically challenged persons. This is a mechanical function related to physical support and movement, not diagnostic testing.
- Device Description: The device is described as a manually operated mechanical wheelchair with typical components like a frame, upholstery, wheels, etc. There is no mention of components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
- Performance Studies: The performance studies mentioned are related to wheelchair standards (ANSI/RESNA and ISO 7176), which focus on mechanical performance, durability, and safety for mobility devices, not diagnostic accuracy.
In summary, the AIDC 8500-II Wheelchair is a mobility aid, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.
AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.
AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Product codes
89IOR
Device Description
The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.
The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.
The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
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
Non-Clinical testing:
AIDC 8500-II wheelchairs have been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC Vol. 1 Sec. 1 Determination of static stability
- (2). ANSI/RESNA WC Vol. 1 Sec. 5 Determination of overall dimensions, mass and turning space
- (3). ANSI/RESNA WC Vol. 1 Sec. 7 Measurement of seating and wheel dimensions
- (4). ANSI/RESNA WC Vol. 1 Sec. 8 Static, impact and fatigue strengths
- (5). ANSI/RESNA WC Vol. 1 Sec. 15 Requirements for the information disclosure, documentation, and labeling
- (6). ANSI/RESNA WC Vol. 1 Sec. 16 Resistance to ignition of upholstered parts
- (7). ISO7176-1 Determination of static stability
- (8). ISO7176-5 Determination of overall dimensions, mass and turning space
- (9). ISO7176-7 Measurement of seating and wheel dimensions
- (10). ISO7176-8 Static, impact and fatigue strengths
- (11).ISO7176-15 Requirements for the information disclosure, documentation, and labeling
- (12). ISO7176-16 Resistance to ignition of upholstered parts
- (13). ISO 7176-19 Wheeled mobility devices for use in motor vehicles
- (14). California Bureau of Home Furnishings 117 Flammability Standards
Key Metrics
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).
0
DEC 1 3 2004
7. 510(k) summary
510(k) Summary
Aerospace Industrial Development Corporation's
AIDC 8500-II Wheelchair
Sponsor's information:
Cycling and Health Tech Industry R&D Center No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan Contact person: Jeff Chang Director of Testing Department Phone: 886-4-23501100 Facsimile: 886-4-22430627 e-mail: jeff-chang@umail.hinet.net Date prepared: November 12, 2004
Proprietary and Manufacturer information:
Aerospace Industrial Development Corporation (AIDC) 111-X60, Lane 68, Fu-Hsing N. Rd., Taichung, Taiwan Contact person: Zen-Jye Chen Manager of Medical Device Section Phone: 886-4-22842291 Facsimile: 886-4-22842849 e-mail: zenjyechen@ms.aidc.com.tw
Device
Trade name: AIDC 8500-11 Wheelchair Common name: Manual Wheelchair Classification name: Mechanical wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3850 Product Code: 89IOR Classification: Class I
1
Predicate devices
Manufacture name: Invacare Corporation Name: Solara Jr. Wheelchair k number: K012370 Date cleared: 8/3/2001
Intend use of device
AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.
AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.
Device description:
The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.
The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.
The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
Substantial equivalence:
The AIDC 8500-11 wheelchair is substantially equivalent to the Solara Jr. Wheelchair (K012370) manufactured by Invacare Corporation.
Analysis of comparison of design, function and feature of AIDC 8500-II wheelchair to Solara Jr. Wheelchair (K012370), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.
2
While there are minor differences in performance specifications of the wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, AIDC believes that the AIDC 8500-II wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
Non-Clinical testing
AIDC 8500-II wheelchairs have been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC Vol. 1 Sec. 1 Determination of static stability
- (2). ANSI/RESNA WC Vol. 1 Sec. 5 Determination of overall dimensions, mass and turning space
- (3). ANSI/RESNA WC Vol. 1 Sec. 7 Measurement of seating and wheel dimensions
- (4). ANSI/RESNA WC Vol. 1 Sec. 8 Static, impact and fatigue strengths
- (5). ANSI/RESNA WC Vol. 1 Sec. 15 Requirements for the information disclosure, documentation, and labeling
- (6). ANSI/RESNA WC Vol. 1 Sec. 16 Resistance to ignition of upholstered parts
- (7). ISO7176-1 Determination of static stability
- (8). ISO7176-5 Determination of overall dimensions, mass and turning space
- (9). ISO7176-7 Measurement of seating and wheel dimensions
- (10). ISO7176-8 Static, impact and fatigue strengths
- (11).ISO7176-15 Requirements for the information disclosure, documentation, and labeling
- (12). ISO7176-16 Resistance to ignition of upholstered parts
- (13). ISO 7176-19 Wheeled mobility devices for use in motor vehicles
- (14). California Bureau of Home Furnishings 117 Flammability Standards
Conclusion
.
- Analysis of comparison of design, function and feature of AIDC 8500-11 Wheelchair to Invacare Solara Jr. Wheelchair, together with the results of compliance testing to existing ANSI/RESNA and ISO 7176 standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting, performance criteria and functioning as intended.
The AIDC 8500-II Wheelchair is substantially equivalent to the predicate device and does not raise any issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve upwards and to the right, resembling a bird in flight. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEC 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cycling and Health Tech Industry R&D Center C/o Mr. Zen-Jye Chen Manager of Medical Device Section Aerospace Industrial Development Corporation (AIDC) 111-X60, Lane 68 Fu-Hsing N. Rd., Taichung Taiwan
Re: K043332
Trade/Device Name: AIDC 8500-II Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: November 12, 2004 Received: December 2, 2004
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) 77 the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, de necs that have been recident is quire approval of a premarket approval application (PMA). and Cosmotion Free (1108) last the device, subject to the general controls provisions of the Act. The Tourmaly, merceive, market are a ct include requirements for annual registration, listing of general controls provisions of uactice, 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 If your device is elassified (600 wor of als. Existing major regulations affecting your device can may or subject to back as a success 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 r lease of deviloed that i Drimination that your device complies with other requirements of the Act that I Dr Has Intelles and regulations administered by other Federal agencies. You must of any I occur statutes and equirements, 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.
4
Page 2 - Mr. Zen-Jye Chen
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance 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 Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Sincerely, your,
Mark A. Millman
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
- Device descriptive information 3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known):
Device Name: ADC 8500-II Wheelchair
Indications for Use:
AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Prescription Use
Over-The-Counter Use - - -
(Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark N. Millerson
(Division Sign-On)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043332
(Posted November 13, 2003)