ORION II (HEAVY DUTY 350 LBS AND 500 LBS)

K101277 · Future Mobility Healthcare, Inc. · IOR · Jun 4, 2010 · Physical Medicine

Device Facts

• Record ID: K101277
• Device Name: ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
• Applicant: Future Mobility Healthcare, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

To provide mobility to persons limited to a sitting position.

Device Story

The ORION II is a mechanical wheelchair designed to provide mobility to individuals restricted to a sitting position. It features a reinforced, wider frame to accommodate higher weight capacities of 350 lbs and 500 lbs. The device includes tilt and recline capabilities and an adjustable back angle. It is operated by the user or a caregiver to facilitate movement. The device is intended for general use to improve patient mobility.

Clinical Evidence

Bench testing only. The device was developed and tested in accordance with ISO 7176 standards, parts 1, 5, 7, 8, and 11, to verify the structural integrity of the reinforced frame for the 350 lbs and 500 lbs weight capacities.

Technological Characteristics

Mechanical wheelchair; reinforced frame construction; tilt and recline capabilities; adjustable back angle. Tested per ISO 7176 (parts 1, 5, 7, 8, 11).

Indications for Use

Indicated for persons limited to a sitting position requiring mobility assistance.

Regulatory Classification

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.

Predicate Devices

• ORION II Wheelchair (K061010)

Submission Summary (Full Text)

{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. [phone])

### Contact:

Mr. Abdulsamad Panchbhaya Toll Free: 1-888-737-4011, Local: 905-671-1661 [e-mail]

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<br>MARKETED<br>PREDICATE<br>DEVICE | MANUFACTURE<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT CODE | 510(K)<br>REGISTRATION<br>NUMBER |
|--------------------------------------------|------------------------------------|-----------------------------------------|----------------------------------|
| ORION II<br>Wheelchair | Future Mobility<br>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.<br>FDA Submittal - SPECIAL 510(k)<br>ORION II (Heavy Duty 350lbs and 500lbs) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ✓ Similar key design technical characteristics- The ORION II Medical device and the Orion<br>(Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical<br>similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back<br>angle and provide similar performance. |
| ✓ The modifications consist of wider frames with a reinforced design to withstand the higher<br>weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight<br>capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths<br>ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32". |
| Conclusion:<br>Future Mobility HealthCare Orion II (Heavy Duty 350lbs and 500lbs) wheelchair was<br>developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11. It is the conclusion<br>that the Future Mobility HealthCare ORION II (Heavy Duty 350lbs and 500lbs) is<br>safe and effective, as well as substantially equivalent to the legally marketed device<br>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 [phone] or [phone] 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