STEALTH PRODUCTS SEATING SYSTEM

K050264 · Stealth Products · ITI · Feb 11, 2005 · Physical Medicine

Device Facts

• Record ID: K050264
• Device Name: STEALTH PRODUCTS SEATING SYSTEM
• Applicant: Stealth Products
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.

Device Story

Battery-powered, motorized seating system for power wheelchairs; provides pressure relief via tilt and recline functions. Components: main frame assembly, system mounting plate, linear actuators, toggle switch assembly. User operates toggle switch to adjust seat/back position. Adaptable to various wheelchair frame geometries (round, square, rectangular). Benefits patient by facilitating pressure redistribution to prevent pressure sores. Used in clinical or home settings by wheelchair-bound individuals.

Clinical Evidence

Bench testing only. Functional performance testing conducted to verify system requirements and specifications.

Technological Characteristics

Battery-powered motorized seating system. Components: main frame, mounting plate, linear actuators, toggle switch. Adaptable to round (1.5" diameter x .09 wall) or square/rectangular (1" surface x .09 wall) frames. Electromechanical actuation. No software or digital connectivity.

Indications for Use

Indicated for power wheelchair users requiring pressure relief through seat and back tilt/recline functionality.

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

• Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119)
• Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804)

Submission Summary (Full Text)

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FEB 1 1 2005

510(k) Premarket Notification

Powered Seating System

K 050264

## 510(k) SUMMARY

# STEALTH PRODUCTS POWERED SEATING SYSTEM FOR POWERED WHEELCHAIRS

#### Submitter

Stealth Products, Inc. 103 John Kelly Drive P.O. Box 468 Burnet, Texas 78611 Phone: [phone] Fax: [phone]

# Contact Person

Edward A. Kroll President Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141 Phone: [phone] Fax: [phone]

Date Prepared: February 1, 2005

#### Name of Device

Stealth Products Powered Seating System for Power Wheelchairs

#### Common or Usual Name

Power Wheelchair Seating System

## Classification Name

Wheelchair, Powered

#### Predicate Devices

Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).

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#### Intended Use

The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.

## Device Description

The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.

The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.

The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.

# Substantial Equivalence

The Stealth Products Powered Seating System is substantially equivalent to Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and the Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).

# Performance Data

Stealth Products has conducted performance and functional testing on the Stealth Products Powered Seating System. In all cases, the Stealth System passed its' performance requirements and met specifications.

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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 features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stealth Products, Inc. C/o Edward A. Kroll President, Representative Consultant Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141

Re: K050264

Trade/Device Name: Stealth Products Powered Seating System for Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 2, 2005 Received: February 4, 2005

Dear Mr. Kroll:

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 for abo cased or 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 - Mr. Kroll

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to cognifinding of substantial equivalence of your device to a legally premarket notification - 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 If you desire specific acries in 1940) 276-0120 . Also, please note the regulation entitled, Colliation of Compunance as (21 t motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on Jour responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

sincerely yours,

Mark A. Melkersen

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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# Indications for Use

510(k) Number (if known): _TBD________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended function and use of the Stealth Products Powered Seating System for Power i he intended function and use of the Steath. Free belief to power wheelchair users, by whechenan's is to provide of tilting and reclining the seat and back.

| Prescription Use<br>AND/OR<br>(Part 21 CFR 801 Subpart D) | |
|-----------------------------------------------------------|---|
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | X |

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

(Division Sign-Off)

Division of General. Restorative, and Neurological Devices

16(k) Number K05 0264