(41 days)
Not Found
No
The description details a purely mechanical wheelchair with no mention of AI or ML features.
No
The wheelchair is intended to provide mobility, but it does not claim to treat or cure any medical condition or directly interact with the body to achieve a therapeutic effect. It serves as a mobility aid.
No
The device is described as a wheelchair intended to provide mobility, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical wheelchair with a steel frame, wheels, and casters, indicating it is a hardware device.
No, 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 physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical wheelchair with a frame, wheels, casters, and upholstery. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key elements typically associated with IVDs, such as:
- Image processing
- AI, DNN, or ML (often used in analyzing diagnostic data)
- Input Imaging Modality
- Anatomical Site (relevant for where a diagnostic test might be applied)
- Training and test set descriptions (crucial for validating diagnostic performance)
- Performance studies and key metrics (essential for demonstrating the accuracy and reliability of a diagnostic test)
Based on the provided information, the Future Mobility HealthCare Inc. Orion II Wheelchair is a mobility aid, not a device used for diagnosing diseases or conditions by examining samples from the body.
N/A
Intended Use / Indications for Use
The Orion II is indicated for providing mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.
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
Koloio
Future Mobility HealthCare FDA Submittal ORION II
SECTION 2.0 SUMMARY OF THE BASIS FOR SUBSTANTIAL EQUIVALENCE
MAY 2 3 2006
510(k) Summary
Submitter:
Future Mobility HealthCare Inc. 2775 Slough Street Mississauga, ON, L4T 1G2 Tel. (1-888-737-4011)
Contact:
Mr. William Salter Toll Free: 1-888-737-4011, Local: 905-671-1661 wtsalter@future-mobility.com
Date: December 12, 2005
Trade Name: Orion II Tilt-in-space wheelchair
Common Name: Wheelchair
Classification Name: Wheelchair, Mechanical
Predicate Devices:
We are making the claim that the Future Mobility Orion II is substantial equivalent to the predicated device listed in the chart below.
| LEGALLY
MARKETED
PREDICATE DEVICE | MANUFACTURE
NAME | REGULATORY
CLASS AND
PRODUCT
CODE | 510(K)
REGISTRATION
NUMBER |
|-----------------------------------------|---------------------|--------------------------------------------|----------------------------------|
| Concept 45 | INVACARE
CORP. | Class I/IOR | K951138 |
The rationale of declaring the new Future Mobility HealthCare Orion II is substantial equivalent to the above predicate device is based on the following:
1
-
Same Indications for use: providing mobility to persons limited to a sitting position.
-
Similar key design technical characteristics- The Invacare Concept 45 Medical device and the Orion II are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar seat depth and widths.
- Similar size, weight, and performance. >
Description:
The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.
Indications for Use:
The Orion II is indicated for providing mobility to persons limited to a sitting position.
Technological Comparison to the Predicate:
Technologically, the Future Mobility HealthCare Orion II wheelchair is substantially equivalent to the Invacare Concept 45 wheelchair. Both devices are compact tilt-nspace chairs which have the same indicated intended use with at least a 45 degree tilt and 30 degree recline option. Both material used are resistance- ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The risks, safety or effectiveness and benefits for the Future Mobility HealthCare Orion II are also comparable. The table of Comparison in Section 6.1 will provide additional information illustrating that the new Future Mobility HealthCare Orion II wheelchair is substantially equivalent to the Invacare Concept 45 wheelchair.
Conclusion:
Future Mobility HealthCare Orion II wheelchair was developed based on the standard ANSI/RESNA Wheelchair Vol.1 which involves ISO 7176. It is the conclusion that the Future Mobility HealthCare ORION II is safe and effective, as well as substantially equivalent to the device identified as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Future Mobility HealthCare, Inc. % Mr. William Salter President & CEO 2775 Slough Street Mississauga, Ontario, L4T 1G2
Re: K061010
Trade/Device Name: Future Mobility HealthCare Inc. Orion II Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 6, 2006 Received: April 12, 2006
Dear Mr. Salter:
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
3
Page 2 - Mr. Bob Gardner
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. 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,
Herbert Lehman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DC. Future Mobility HealthCare FDA Submittal ORION II
Indications for Use
061010 510(k) Number (if known
Device Name: Future Mobility HealthCare Inc. Orion II Wheelchair
Indications for Use:
The Future Mobility HealthCare Inc. Orion II 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K061010