(93 days)
Not Found
No
The description clearly states the device is a "manually operated, self propelled mechanical wheelchair" and there is no mention of AI, ML, or any related technologies in the summary.
No
The device is a wheelchair, which provides mobility assistance rather than therapy or treatment for a disease or condition.
No
The device is a wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a "manually operated, self propelled mechanical wheelchair" consisting of "folding mechanical aluminum frames," indicating it is a physical hardware device.
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 to persons limited to a sitting position." This is a mechanical function for physical support and movement, not for diagnosing a condition or analyzing biological samples.
- Device Description: The description details a "manually operated, self propelled mechanical wheelchair" with a "folding mechanical aluminum frame." This aligns with a physical mobility aid, not an in vitro diagnostic device.
- 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is a mobility device, not an IVD.
N/A
Intended Use / Indications for Use
The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.
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)
Not Found
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
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
Future Mobility Healthcare Inc. FDA Submittal - 510(k) GALAXY LITE
510(k) Summary
Submitted by:
OCT 2 0 2010
Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga, ON, LAV 1C5 Tel. (1-888-737-4011)
. •
Contact:
Mr. Abdul Panchbhaya Toll Free: 1-888-737-4011, Local: 905-671-1661 abdul@future-mobility.com
Date: July 7, 2010
Trade Name: Galaxy Lite Folding mechanical wheelchair
Common Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical
Predicate Devices:
| LEGALLY
MARKETED
PREDICATE
DEVICES | MANUFACTURER
NAME | REGULATORY
CLASS AND
PRODUCT CODE | 510(K)
REGISTRATION
NUMBER |
|---------------------------------------------|------------------------------------------------------|-----------------------------------------|----------------------------------|
| Quickie 2 HP | Motion Design Inc
(Sunrise Medical
Design Inc) | Class I/IOR | K890050 |
| Stellato | Future Mobility
Healthcare, In. | Class I/IOR | K061010 |
1
Future Mobility Healthcare Inc. FDA Submittal - 510(k) GALAXY LITE
The rational of declaring the Future Mobility Healthcare Galaxy Lite is substantially equivalent to the above predicate devices is based on the following:
Same Indications for use: providing mobility to persons limited to a sitting position.
- Similar key design technical characteristics- The Quickie 2 HP, Stellato and Galaxy Lite > are mechanical wheelchairs which have technical similarities. The Quickie 2 HP and Galaxy Lite contain an adjustable rear wheel location and provide similar performance.
-
The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.
Conclusion:
Future Mobility HealthCare Galaxy Lite folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11. It is the conclusion that the Future Mobility HealthCare Galaxy Lite is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices identified as the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Future Mobility HealthCare Inc. % Mr. Abdul Panchbhaya President & CEO 3223 Orlando Drive Mississauga, Ontario Canada L4V 1C5
OCT 2 0 2010
Re: K102031
Trade/Device Name: Future Mobility Healthcare Inc. Galaxy Lite Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 3, 2010 Received: September 3, 2010
Dear Mr. Panchbhaya:
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 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
3
Page 2 - Mr. Abdul Panchbhaya
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.
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, "Mishranding 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Millians
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
| 510(k) Number (if known): | K102031 |
|---|---|
| OCT. 20 2010 | |
| Device Name: | Future Mobility Healthcare Inc. Galaxy Lite |
| Indication for Use: | |
| The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting 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 Devise Evaluation (ODE)
..............................................................................................................................................................................
Kammel D. Taylor
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
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