TISPORT X AND TISPORT XC

K990555 · Tisport · IOR · Mar 22, 1999 · Physical Medicine

Device Facts

• Record ID: K990555
• Device Name: TISPORT X AND TISPORT XC
• Applicant: Tisport
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.

Device Story

TiSport X and XC are folding manual wheelchairs for everyday mobility. Device provides mobility to physically impaired individuals. Operated by the user or caregiver. Frame manufactured from titanium, offering superior strength-to-weight ratio compared to aluminum. High degree of customization allows for proper clinical fitting, enhancing safety and access to accessories. Used in clinical or home settings. Benefits include improved mobility, safety, and ergonomic fit for patients with various physical impairments.

Clinical Evidence

Bench testing only. Device meets requirements of ISO 7176 Parts 1, 3, 5, 7, and 8.

Technological Characteristics

Folding manual wheelchair. Frame material: Titanium. Standards: ISO 7176 Parts 1, 3, 5, 7, and 8. Mechanical operation.

Indications for Use

Indicated for physically impaired individuals requiring mobility assistance for everyday use, including patients 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 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

• Quickie 2HP (K890050)

Submission Summary (Full Text)

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3/22/99

Image /page/0/Figure/1 description: The image is a black square with the letters 'Ti' in white, stacked vertically. Above the 'i' is a white circle. Below the letters, the word 'SPORT' is written in white, with each letter centered under the 'Ti' letters above. The image appears to be a logo.

K990555

THE TITA

## 510(k) SUMMARY

Date: February 19, 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: TiSport X and TiSport XC

Common Name: Folding manual wheelchair

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

Classification: Class I

Panel: Physical Medicine Device Prosthetic Devices Subpart D

Product Code: 89IOR (Mechanical Wheelchair)

Legally Marketed Device Claiming Equivalence To: Quickie 2HP (K890050)

Description of Device: The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.

Intended Use of the Device: The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair. It is intended to provide mobility to physically impaired individuals. The manual folding wheelchair is intended for on-going "everyday" use.

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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Testing Results: Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable).

Device Comparison: There are no significant differences between the submitted device (TiSport X) and the predicate device (Quickie 2HP). The only apparent differences between the two folding wheelchairs is 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 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. 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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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" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle, with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 1999

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

Re: K990555 TiSport X and TiSport XC Trade Name: Regulatory Class: I Product Code: IOR 1999 Dated: February 19, February 22, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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. concerning your device in the Federal Register. Please note: 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990555 10(k) Number (if known):

TiSport X and TiSport XC Device Name:

ndications For Use:

The intended use of this device (folding manual wheelchalr) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K990555 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span style="text-decoration: overline;">X</span> |
|------------------------------------------|----|------------------------------------------------------------------------|
|------------------------------------------|----|------------------------------------------------------------------------|

(Optional Format 1-2-96)

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