TIPOWER POWERDRIVE AND RIMPOWER X & SX

K020539 · Tisport · ITI · Jun 20, 2002 · Physical Medicine

Device Facts

• Record ID: K020539
• Device Name: TIPOWER POWERDRIVE AND RIMPOWER X & SX
• Applicant: Tisport
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

Device Story

Folding power/manual wheelchair; titanium frame construction; aluminum cross tubes. Provides mobility to physically impaired individuals; allows user to switch between battery-powered propulsion and manual propulsion by disengaging drive mechanism. Features hub-mounted motors and compact batteries. Used in clinical or home settings; operated by patient. Titanium frame offers superior strength-to-weight ratio and vibration absorption compared to aluminum. Hub-mounted motor design increases energy efficiency and reduces required human propulsion effort. Rear wheels interchangeable with lighter manual versions. Customization options facilitate proper clinical fitting, enhancing safety and accessibility.

Clinical Evidence

Bench testing only. Device met requirements of ISO 7176 (Parts 1, 3, 5, 7, 8), ANSI/RESNA WC/Vol. 2-1998 Section 21, and EN 12184:1999.

Technological Characteristics

Titanium frame; aluminum cross tubes. Hub-mounted electric motor; battery-powered. Folding form factor. Standards: ISO 7176 (Parts 1, 3, 5, 7, 8), ANSI/RESNA WC/Vol. 2-1998 Section 21, EN 12184:1999. No software or electronic algorithm described.

Indications for Use

Indicated for physically impaired individuals requiring mobility assistance, including those with spinal cord injury, stroke/CVA, post-polio syndrome, spina bifida, amputation, multiple sclerosis, arthrogryposis, muscular dystrophy, and lower/upper extremity paralysis.

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

• Commuter (K934232)

Submission Summary (Full Text)

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JUN 2 0 2002

Image /page/0/Picture/1 description: The image is a logo with a black background. The letters 'Ti' are stacked vertically in white, with a white circle above the 'i'. Below the letters, the word 'SPORT' is written in smaller white letters. The logo appears to be for a sports-related brand or organization.

K020534
1052

THE TITANIUM WHEELCHAIR COMPANY

## 510(k) SUMMARY

Date: February 15, 2002

## Present by:

Ms. Sandra Gladstone TiSport 1426 East Third Avenue Kennewick, WA 99337 509-586-6117 ext. 260 509-586-2413 fax

Trade / Proprietary Name: TiPower RimPower X and SX and TiPower PowerDrive X and SX

Common Name: Folding power/manual wheelchair

Classification Name: Powered Wheelchair (per 21 CFR section 890.3850)

Classification: Class II

Panel: Physical Medicine Device Prosthetic Devices Subpart D

Product Code: 890.3860 (Powered Wheelchair)

Legally Marketed Device Claiming Equivalence To: Commuter (K934232)

Description of Device: The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.

Intended Use of the Device: The intended use of this device is the same as the predicate device, the Commuter, manufactured by Fortress Lite-Style Wheelchairs, Inc. It is intended to provide mobility to physically impaired individuals while providing them with a power or manual propulsion method.

Target Population: The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

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K020539
20r2

Testing Results: Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable) and ANSI/RESNA WC/Vol. 2-1998 Section 21 and EN 12184:1999.

Device Comparison: There are no significant functionality differences between the submitted device and the predicate device. However, the differences between the Commuter folding power/manual wheelchair and the TiPower RimPower and PowerDrive X and SX folding power/manual wheelchair are the materials used in the manufacturing of the frame and the power packs are made from a different company. The Commuter frame material is aluminum where the TiPower chair frames are made of titanium and the cross tubes are made from aluminum. TiSport believes that manufacturing the frames out of titanium vs. aluminum is a benefit not only from a safety perspective but clinically as well because of titanium's proven superior strength-to-weight ratio and its natural ability to absorb vibration. The power unit on the TiPower chairs performs the same function as the Commuter's power unit but we believe it is better because the battery is significantly smaller and lighter and the motor is in the wheel hub verses being mounted to the frame. The chair requires less human propulsion to move the chair and the power unit is more energy efficient. The rear wheels can be changed easily to lighter weight manual rear wheels. The TiPower offers a wider range of customization allowing for a better opportunity to properly "fit" the end user in a clinical setting as well as ensuring better safety and access to the chairs options and accessories.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2002

Ms. Sandra Gladstone Vice President Operations TiSport 1426 East Third Avenue Kennewick, WA 99337

Re: K020539

Trade Name: TiPower RimPower and PowerDrive X & SX Regulatory Number: 890.3860 Regulatory Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 12, 2002 Received: April 15, 2002

Dear Ms. Gladstone

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 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.

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Page 2 - Ms. Sandra Gladstone

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Mark A. Milliken

Celia 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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Ver/3-4/24/06

Applicant: TiSport

501(k) Number (if known): _

K020539

Devise Name: TiPower RimPower and PowerDrive X & SX

Indication for Use:

The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mellman

Division Sign-Division of General, Restorative and Neurologica

510(k) Number K020

(Per 21 CFR 801.109) Optional Format 1-2-96