TILITE AERO X

K072311 · Tisport, LLC · IOR · Sep 21, 2007 · Physical Medicine

Device Facts

• Record ID: K072311
• Device Name: TILITE AERO X
• Applicant: Tisport, LLC
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals. The TiLite Aero X folding manual wheelchair is intended for ongoing daily use.

Device Story

TiLite Aero X is a folding manual wheelchair designed for ongoing daily mobility. Constructed from tubular and extruded aluminum alloy, it provides a platform for physically impaired individuals. The device features adjustable components, including camber plugs for rear wheel adjustment and a multi-position front caster attachment system, allowing for clinical customization to improve user fit, safety, and access. It is intended for use by patients with various immobilizing conditions. The device is operated by the user or a caregiver. It functions as a mechanical mobility aid; no electronic or software components are involved.

Clinical Evidence

Bench testing only. The device was evaluated against ANSI/RESNA WC/Volume 1: 1998, Sections 1, 5, 7, 8, 16, and 93.

Technological Characteristics

Folding manual wheelchair; frame and folding mechanism made of aluminum alloy; mechanical adjustment systems for rear wheel camber (camber plugs) and front caster positioning; manual operation; no electronic components or software.

Indications for Use

Indicated for individuals with mobility impairments, including amputees, arthritis, arthrogryposis, cerebral palsy, geriatric conditions, head injury/trauma, hemiplegia, multiple sclerosis, muscular dystrophy, paraplegia, polio, quadriplegia, spina bifida, stroke/CVA, tetraplegia, and other immobilizing or debilitating conditions involving lower or 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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K072311

# 510(k) SUMMARY

SEP 2 1 2007

#### (As Required by 21 CFR 807.92(c))

#### Submitted By:

TiSport, LLC 1426 Fast Third Avenue Kennewick, WA 99337 Telephone: [phone] Telecopier: 509-586-2413

# Contact Person:

Richard S. Forman, President & Chief Legal Officer

## Date:

August 15, 2007

#### Trade Name of Device:

TiLite Aero X

### Common Name of Device:

Folding Manual Wheelchair

### Classification Name of Device:

Wheelchair, Mechanical (21 CFR 890.3850; Product Code IOR)

### Classification of Device:

Class I

# Panel:

Physical Medicine Prosthetic Devices

#### Legally Marketed Predicate for Claimed Substantial Equivalence:

Quickie 2HP (K890050) manufactured by Sunrise Medical, Inc., successor to Mobility Designs, Inc.

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# Description of Device:

The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.

#### Intended Use of Device:

The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals. The TiLite Aero X folding manual wheelchair is intended for ongoing daily use.

#### Target Patient Population:

The TiLite Aero X device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such specific medical conditions: Amputee; Arthritis; Arthrogriposis; Cerebral Palsy; Geriatric Conditions; Head Injury or Trauma; Hemiplegic; Multiple Sclerosis; Muscular Dystrophy; Paraplegic; Polio; Quadraplegic; Spina Bifida; Stroke/CVA; Tetraplegic; and other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

#### Device Comparison:

There are no significant differences between the TiLite Aero X and the predicate device. The only apparent difference between the predicate device and the TiLite Aero X is that the TiLite Aero X offers the ability to customize and adjust the device to a greater degree than does the predicate device. The degree of customization and adjustment allows for a better opportunity to properly "fit" the user/operator of the wheelchair in a clinical setting and should permit better safety and access to the product's options and accessories. There are also certain technological differences between the TiLite Aero X and the predicate device that result in improved functionality. For example, the mechanism to add camber to the rear wheels uses camber plugs on the TiLite Aero X whereas the mechanism to add camber to the rear wheels uses washers on the predicate device. The mechanism to attach the front casters to the TiLite Aero X allows for a much greater degree of adjustability forward and rearward, whereas there are only two positions in which the front casters can be mounted on the predicate device.

#### Testing Results:

The TiLite Aero X will meet the requirements of ANSI/RESNA WC/Volume 1: 1998, Sections 1, 5, 7, 8, 16 and 93.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

#### Public Health Service

SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TiSport, LLC % Mr. Richard S. Forman President & Chief Legal Officer 1426 East Third Avenue Kenwick, WA 99337

Re: K072311

> Trade/Device Name: TiLite Aero X Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 15, 2007 Received: August 17, 2007

Dear Mr. Forman:

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, RDA max 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. Your 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 eectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

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Page 2 - Mr. Richard S. Forman

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

# 510(k) Number (if known):

# Device Name:

TiLite Aero X

# Indications for Use:

:

The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | Yes |
|-------------------------------------------------|-----|
|-------------------------------------------------|-----|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | Yes |
|------------------------------------------------|-----|
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE).

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K072311 |
|---------------|---------|
|---------------|---------|

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