CROSS SPORT, RIGID WHEELCHAIR

K990358 · Tisport · IOR · Feb 26, 1999 · Physical Medicine

Device Facts

• Record ID: K990358
• Device Name: CROSS SPORT, RIGID WHEELCHAIR
• Applicant: Tisport
• Product Code: IOR · Physical Medicine
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.

Device Story

Cross-Sport is a custom, rigid, manual wheelchair designed for everyday and recreational sports use. Constructed from titanium, the device provides mobility to physically impaired individuals. The chair is manufactured to specific user measurements to ensure proper fit, safety, and access to options. It is operated by the user. The device serves as a mobility aid, with the titanium frame offering a superior strength-to-weight ratio compared to traditional chromoly frames, potentially enhancing safety and clinical outcomes.

Clinical Evidence

Bench testing only. The device meets the requirements of ISO standards.

Technological Characteristics

Rigid manual wheelchair; frame constructed from titanium; custom-fitted to user specifications; mechanical operation; no electronic components or software.

Indications for Use

Indicated for physically impaired individuals requiring mobility assistance for everyday use or recreational sports. Conditions include, but are not limited to, spinal cord injury, post-polio, spina bifida, and amputee status.

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

• Shadow Rigid (K925451)

Submission Summary (Full Text)

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Ti
SPORT

K990358

## 510(k) SUMN

Date: February 4, 1999

Present by:

Ms. Sandra Gladstone TiSport 1426 East Third Avenue Kennewick, WA 99337 509-586-6117 ext. 233 509-586-2413 fax

Trade / Proprietary Name: Cross Sport

Common Name: Rigid Wheelchair

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

Classification: Class I

Panel: Physical Medicine

Product Code: 89IOR (Mechanical Wheelchair)

Legally Marketed Device Claiming Equivalence To: Shadow Rigid (K925451)

Description of Device: The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.

Intended Use of the Device: The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.

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

Spinal chord injury Post polio Spina Bifada Amputee

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Testing Results: Meets the requirements of the ISO Standards.

Device Comparison: There are no significant differences between the submitted device and the predicate device (k925451). The only apparent differences between the Shadow rigid wheelchair and the TiSport Cross-Sport are the materials used in the manufacture of the frame and the degree of customization offered to the consumer/operator. TiSport believes that manufacturing the frame of the Cross-Sport out of titanium vs. chromoly is a benefit not only from a safety perspective but clinically as well because of titanium's proven superior strength-to-weight ratio. The degree of customization allows for a better opportunity to properly "fit" the operator in a clinical setting as well as ensuring better safety and access to the chairs options and accessories.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

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

K990358 Re: Cross-Sport, Rigid Wheelchair Trade Name: Regulatory Class: I IOR Product Code: February 4, 1999 Dated: February 5, 1999 Received:

Dear Ms. Gladstone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Sandra Gladstone

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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1990358 501(k) Number (if known): _

Devise Name: Cross Sport

Indication for Use:

The intended use of this device (manual wheelchair) is the same as the predicate device (Shadow rigid wheelchair {K925451} by Magic In Motion now owned by Quickie).

It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications.

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

Spinal chord injury Post polio Spina Bifada Amputee

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use