IGLIDE MANUAL ASSIST WHEELCHAIR

K030250 · Independence Technology, LLC · ITI · Mar 4, 2003 · Physical Medicine

Device Facts

• Record ID: K030250
• Device Name: IGLIDE MANUAL ASSIST WHEELCHAIR
• Applicant: Independence Technology, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.

Device Story

Manual assist wheelchair providing mobility to seated users; utilizes sensors and controllers to measure effort applied to handrims; calculates force differential between user input and required propulsion; electric motors provide auxiliary power to negotiate surfaces with reduced user effort; device includes gearbox, motor controller for each side, and battery; operated by user via handrims; on/off switch located under seat; benefits patient by reducing physical exertion required for mobility.

Clinical Evidence

No clinical data; bench testing not required as the subject device is identical to the predicate device.

Technological Characteristics

Powered wheelchair with manual assist; includes gearbox, motor controllers, and battery; sensing/actuation via handrim sensors and electric motors.

Indications for Use

Indicated for individuals limited to a seated position who possess the capability to operate a manual or power wheelchair.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• TAILWIND Power Assist Wheelchair

Submission Summary (Full Text)

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# 510(k) Summary

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Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917

#### Contact Person

James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917 908 - 412 - 2266 jodonnel(@indus.jnj.com

#### Date Prepared

January 22, 2003

#### Name of Device

INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair

#### Classification Name

Wheelchair, Powered

#### Identification of Predicate Device

TAILWIND Power Assist Wheelchair

#### Description of Device

The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.

The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.

#### Intended Use

The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.

MAR 0 4 2003

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VIND Power

20F
K030250

Comparison to Predicate Device
The NOPERNDENCE (TM) Namal Asist Wirelchair is the TALL TALL TALL PALL POS PORT POS PORT POST POST OF OF OF OF
Assis Wheeldair. The only Artes the TAILWIND Power Assist Wheelchair does have the Statement.

### Non-Clinical Tests Performed

Because the new and predicate devices are the same device, no new testing is needed.

#### Summary

The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. The removal of the Prescription Device Statement does not raise any questions of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Mr. James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O. Box 4917 Warren, NJ 07059-4917

Re: K030250

Trade/Device Name: iGlide™ Manual Assist Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 23, 2003 Received: January 24, 2003

Dear Mr. O'Donnell:

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. Iisting 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. James P. O'Donnell

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Mellemson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO30250

iglide™ Manual Assist Wheelchair Device Name:

#### Indications For Use:

The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manua or power wheelchair.

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Concurrence of CDRH, Office of Device Evaluation

Jivision Sign-Off Division of General, Restorative I Neurological Devices

K030250
Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Formst 1-2-96)