SUPER CHAIR FOR KIDS BY ORION

K103073 · Future Mobility Healthcare, Inc. · IOR · Jan 3, 2011 · Physical Medicine

Device Facts

• Record ID: K103073
• Device Name: SUPER CHAIR FOR KIDS BY ORION
• Applicant: Future Mobility Healthcare, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

Intended 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.

Device Story

Super Chair for Kids by Orion is a manual, tilt-in-space mechanical wheelchair; designed for pediatric use. Device provides mobility to individuals limited to a sitting position; supports patients up to 150 lbs. Operated by patient (self-propelled) or attendant. Features mechanical steel frame; includes motor vehicle transport tie-down system. Used in clinical or home environments to facilitate patient mobility and positioning. Benefits include improved patient mobility and safe transport in motor vehicles.

Clinical Evidence

Bench testing only. Device developed in accordance with ISO 7176 parts 1, 5, 7, 8, 11, and 19. No clinical data provided.

Technological Characteristics

Mechanical wheelchair; steel frame construction. Tilt-in-space functionality. Manual operation; self-propelled or attendant-propelled. Compliant with ISO 7176 (stability, dimensions, static/impact/fatigue strength, test dummies) and ANSI/RESNA WC/Vol.1 (motor vehicle transport tie-down systems).

Indications for Use

Indicated for persons limited to a sitting position, including pediatric patients weighing up to 150 lbs, requiring mobility assistance via a manual wheelchair.

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

• Zippie TS (K890050, K973673)
• ORION II (K061010)

Submission Summary (Full Text)

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JAN - 3 2010

K103073

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. [phone])

### Contact:

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

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<br>MARKETED<br>PREDICATE<br>DEVICES | MANUFACTURER<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT CODE | 510(K)<br>REGISTRATION<br>NUMBER |
|---------------------------------------------|-------------------------------------|-----------------------------------------|----------------------------------|
| Zippie TS | Sunrise Medical | Class I/IOR | K890050<br>K973673 |
| ORION II | Future Mobility<br>Healthcare, Inc. | Class I/IOR | K061010 |

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### 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.

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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

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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 [phone] or [phone] 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

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# 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)

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Concurrence of CDRH, Office of Devise Evaluation (ODE)

Koumer Plage

on of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103073