(29 days)
Not Found
No
The description focuses on mechanical modifications for increased weight capacity and references ISO standards for performance, with no mention of AI or ML.
No
The device is a wheelchair which provides mobility, not a therapeutic treatment.
No
The intended use of the device is to provide mobility, not to diagnose a medical condition.
No
The device description explicitly states it is a "mechanical wheelchair" and details physical modifications to the frame for increased weight capacity. This indicates it is a hardware device, not software-only.
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 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 mechanical wheelchair with features like tilt and recline. It focuses on the physical structure and function of the device for mobility.
- 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
- Reagents, calibrators, or controls
- Laboratory procedures
This device is clearly a medical device designed for mobility assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".
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
Future Mobility Healthcare Inc.
K101277
JUN-4 2010
Future Mobility He Ilthcare Inc. FDA Submittal - SPE CIAL 510(k) ORION II (Heavy Duty 35015 and 500lbs)
510(k) Summary
Submitted by:
Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga, ON, L4V 1C5 Tel. (1-888-737-4011)
Contact:
Mr. Abdulsamad Panchbhaya Toll Free: 1-888-737-4011, Local: 905-671-1661 abdul@future-mobility.com
Date: March 26, 2010
Trade Name: ORION 11 (Heavy Duty 350lbs and 500lbs) mechanical wheelcha
Common Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical
Predicate Device:
We are making the claim that the modified ORION 11 (Heavy Duty 350Ibs and S Olbs) is substantially equivalent to the prodicated device listed in the chart bclow.
| LEGALLY
MARKETED
PREDICATE
DEVICE | MANUFACTURE
NAME | REGULATORY
CLASS AND
PRODUCT CODE | 510(K)
REGISTRATION
NUMBER |
|--------------------------------------------|------------------------------------|-----------------------------------------|----------------------------------|
| ORION II
Wheelchair | Future Mobility
Healthcare Inc. | Class I/IOR | K061010 |
The rationale of declaring the modified Future Mobility HealthCare Orion 11 (He ivy Duty 350lbs and 500lbs) is substantial equivalent to the above predicate device is base on the following:
Same Indications for use: providing mobility to persons limited to a sitting p sition.
1
| Future Mobility Healthcare Inc.
FDA Submittal - SPECIAL 510(k)
| ORION II (Heavy Duty 350lbs and 500lbs) |
|---|
| ✓ Similar key design technical characteristics- The ORION II Medical device and the Orion |
| (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical |
| similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back |
| angle and provide similar performance. |
| ✓ The modifications consist of wider frames with a reinforced design to withstand the higher |
| weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight |
| capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths |
| ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32". |
| Conclusion: |
| Future Mobility HealthCare Orion II (Heavy Duty 350lbs and 500lbs) wheelchair was |
| developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11. It is the conclusion |
| that the Future Mobility HealthCare ORION II (Heavy Duty 350lbs and 500lbs) is |
| safe and effective, as well as substantially equivalent to the legally marketed 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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Future Mobility HealthCare, Inc. % Mr. Abdulsamad Panchbhaya President & CEO 3223 Orlando Drive Mississauga, Ontario Canada L4V 1C5
JUN - 4 2010
Re: K101277
Trade/Device Name: Future Mobility Healthcare Inc. ORION II (Heavy Duty 3501bs and 500lbs)
Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 26, 2010 Received: May 6, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Abdulsamad Panchbhaya
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/CDRHQffices/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/ReportalProblem/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,
for
Mark N. Melkerson
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):
Device Name: Future Mobility Healthcarc Inc. ORION II (Heavy Duty 350lbs) nd 5001bs)
Indication for Use:
To provide mobility to persons limited to a sitting position.
Prescription Usc
AND/OR
Over-The-Counter Usc
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTH IR PAGE IF NEEDED)
Concurrence of CDRH, Office of Devise Evaluation (ODE)
Signature Sign Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101277