(77 days)
Not Found
No
The device description explicitly states it is a "manually operated, self propelled mechanical wheelchair" and there are no mentions of AI, ML, or related terms in the provided text.
No
The chair is intended to provide mobility, but it does not claim to treat or cure any medical condition, which is a characteristic of a therapeutic device.
No
The device description states its purpose is to "provide mobility to persons limited to a sitting position" and describes it as a "manually operated, self propelled mechanical wheelchair." There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states it is a "manually operated, self propelled mechanical wheelchair" consisting of "mechanical steel frames," indicating it is a physical hardware device, not software only.
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 describes a physical aid for mobility, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a "manually operated, self propelled mechanical wheelchair." This is a mechanical device for physical support and movement.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or assays
The device is clearly a mobility aid, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The ORION II, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs. The Zippie TS and the Super Chair for Kids by Orion are designed with motor vehicle transport tie down systems that satisfy safety standard in accordance with procedures set forth in Annex A of Section 19, ANSI/RESNA WC/Vol.1 Wheelchairs Used as Seats in Motor Vehicles.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JAN - 3 2010
Future Mobility Healthcare Inc. FDA Submittal - 510(k) SUPER CHAIR FOR KIDS BY ORION
510(k) Summary
Submitted by:
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: October 11, 2010
Trade Name: Super Chair for Kids by Orion Tilt in Space 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 |
|---------------------------------------------|-------------------------------------|-----------------------------------------|----------------------------------|
| Zippie TS | Sunrise Medical | Class I/IOR | K890050
K973673 |
| ORION II | Future Mobility
Healthcare, Inc. | Class I/IOR | K061010 |
1
Future Mobility Healthcare Inc. FDA Submittal - 510(k) SUPER CHAIR FOR KIDS BY ORION
The rational of declaring the Future Mobility Healthcare Super Chair for Kids by Orion 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 ORIONII, Zippie TS and Super Chair for Kids by Orion are mechanical wheelchairs which have technical similarities.
-
The ORION II, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.
- V The Zippie TS and the Super Chair for Kids by Orion are designed with motor vehicle transport tie down systems that satisfy safety standard in accordance with procedures set forth in Annex A of Section 19, ANSI/RESNA WC/Vol.1 Wheelchairs Used as Seats in Motor Vehicles.
Conclusion:
Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1. 5. 7. 8. 11 and 19. It is the conclusion that the Future Mobility HealthCare Super Chair for Kids by Orion is safe and effective, as well as substantially equivalent to the legally marketed device 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 eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Future Mobility Healthcare, Inc. % Mr. Abdulsamad Panchbhaya 3223 Orlando Drive Mississauga. Ontario Canada L4V 1C5
JAN - 3 20.0
Re: K103073
Trade/Device Name: Future Mobility Healthcare Inc. Super Chair for Kids by Orion Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 11, 2010 Received: October 18, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Mr. Abdulsamad Panchbhava
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 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, "Misbranding 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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
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): K163073
Device Name: Future Mobility Healthcare Inc. Super Chair for Kids by Orion
Indication for Use:
The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
JAN - 3 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
Concurrence of CDRH, Office of Devise Evaluation (ODE)
Koumer Plage
on of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103073