(24 days)
Not Found
No
The device description and performance studies indicate a standard, manually operated mechanical wheelchair with no mention of AI or ML capabilities.
Yes
The device is a wheelchair, which is used to provide mobility to physically challenged individuals. This falls under the definition of a therapeutic device as it helps to alleviate a physical impairment.
No
The device is described as a manually operated mechanical wheelchair designed to provide mobility, not to diagnose medical conditions.
No
The device description explicitly states it is a "manually operated mechanical wheelchair" consisting of physical components like a metal frame, upholstery, footrests, casters, and wheels. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide enhanced mobility to physically challenged persons. This is a mechanical function for physical support and movement.
- Device Description: The description details a manual wheelchair with mechanical components like a frame, wheels, and upholstery. There is no mention of analyzing biological samples or providing diagnostic information.
- 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 the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is clearly a medical device, specifically a mobility aid, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Galaxy Series Wheelchair provides enhanced mobility to physically challenged Persons limited to a sitting position.
Product codes
IOR
Device Description
The Galaxy Series 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 Galaxy Series Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.
The users manual of Galaxy Series 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission.
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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 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
DEC 2 7 2002
510(k) SUMMARY
| Submitter's name: | Evermed Corporation |
|---|---|
| Submitter's address: | 4999 E. La Palma Ave. |
| Anaheim, CA 92807 | |
| Submitter's phone number: | (714) 777-9997 |
| Date summary prepared: | November 27, 2002 |
| Proprietary name: | Galaxy Series Wheelchair |
| Common or usual name: | Wheelchair |
| Classification name: | Wheelchair, mechanical |
| Predicate device: | Breezy Series Wheelchair manufactured by Sunrise |
| Medical, Inc. (K974820) |
Intend use of device:
The Galaxy Series Wheelchair provides enhanced mobility to physically challenged Persons limited to a sitting position.
Technological Characteristics and Substantial Equivalence:
Device description:
The Galaxy Series 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 Galaxy Series Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.
The users manual of Galaxy Series Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
1
Substantial equivalence:
The Galaxy Series Wheelchair is substantially equivalent to the Breezy Series Wheelchair manufactured by Sunrise Medical, Inc. (K974820). They both have the same technological characteristics and intended use of the device.
Testing conducted:
Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
DEC 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Evermed Corporation Calvin Chang 4999 East La Palma Avenue Anaheim. California 92807
Re: K023993
Trade/Device Name: Galaxy Series Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: November 27, 2002 Received: December 3, 2002
Dear Mr. Chang:
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
3
Page 2 - Mr. Calvin Chang
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.
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 (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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
e Marla N 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
4
Indications for Use Statement
510(k) Number (if known):
Device name: Galaxy Series Wheelchair
. . . . . . .
Indications for Use: The Galaxy Series Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.
(Please do not write below this line) -_-----------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Mark N. Milkerson
KO23993
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Notification - Galaxy Series Wheelchair
C