MODEL ACTION AT II MANUAL WHEELCHAIR

K984447 · Invacare Corp. · IOR · Jan 8, 1999 · Physical Medicine

Device Facts

• Record ID: K984447
• Device Name: MODEL ACTION AT II MANUAL WHEELCHAIR
• Applicant: Invacare Corp.
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The intended use of the Model Action AT II Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Device Story

Manually operated, rigid, non-folding mechanical wheelchair; provides mobility for individuals restricted to sitting position. Features include steel frame, rear wheels with handrims, front pivoting casters, and solid seating surface. Incorporates manually operated 'Tilt in Space' mechanism (55-degree range) for patient stability, comfort, head control, or attendant-assisted care (e.g., feeding). Attendant version includes stroller-style push handle. Operated by user or attendant in clinics, hospitals, nursing homes, or extended care facilities. Tilt adjustment achieved via rear release levers, flexible cables, and gear rack/actuator rod system. No electronic or software components.

Clinical Evidence

Bench testing only. Device performance verified against ANSI/RESNA WC/Vol.1-1998 and DIS ISO 7176 (1992) Part 8 standards for static, impact, and fatigue strength.

Technological Characteristics

Rigid, non-folding frame constructed from 1/4" and 1" OD round mechanical steel tubing. Welded side frames with screw/bolt assembly. Manual 'Tilt in Space' mechanism uses release levers, flexible cables, gear rack segments, and notched actuator rods. 55-degree tilt range. Complies with ANSI/RESNA WC/Vol.1-1998 and ISO 7176 standards.

Indications for Use

Indicated for persons limited to a sitting position requiring mobility assistance; suitable for use as a self-propelled or attendant-propelled device in clinical or home environments.

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

• Sunrise Medical/Quickie Design Model 'Quickie TSR' Manual Wheelchair (K952641)
• Invacare Model Action AT Manual Wheelchair (K941989)

Submission Summary (Full Text)

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984447

## 510(k) SUMMARY

## Invacare Corporation's Model Action AT II Manual Wheelchair

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

Contact Person:

Edward A. Kroll Director, TQM and Regulatory Affairs

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December 11, 1998 Date Prepared:

## Name of Device and Name/Address of Sponsor

Model Action AT II Manual Wheelchair

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: (440) 36-4558

## Common or Usual Name: Manual Wheelchair

Classification Name: Wheelchair, Mechanical 89IOR

Predicate Devices

The Invacare Model Action AT II substantially equivalent to the Sunrise Medical/Quickie Design Model "Quickie TSR" Manual Wheelchair (K952641 6/9/95) and the Invacare Model Action AT Manual Wheelchair (K941989 6/11/94).

Intended Use: The intended use of the Model Action AT II Manual Wheelchair is to provide mobility to persons limited to a sitting position.

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## Technological Characteristics and Substantial Equivalence

- A. Device Description The Invacare Corporation Model Action AT II is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or extended care facility.
The product consists basically of the wheelchair frame, larger rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning.

The wheelchair frame is constructed from both 1/4" and 1" outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems currently available in the market.

The Action AT II also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some fashion. The attendant version of the chair also is available with a stroller type push handle for ease of attendant pushing.

The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever diseneage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 55 degrees.

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## B. Substantial Equivalence

The Invacare Model Action AT II substantially equivalent to numerous manual, mechanical wheelchairs currently in market place, for which FDA has granted marketing clearance through the 510(k) premarket notification process. More specifically the Invacare Action AT II is substantially equivalent to the Sunrise Medical/Quickie Design Model "Quickie TSR" Manual Wheelchair (K952641 6/9/95) and the Invacare Model Action AT Manual Wheelchair (K941989 6/11/94).

Each of the products is a manually operated, attendant or user propelled, manual mechanical wheelchair with the same intended function and use which is to provide mobility to persons that may be limited to a seated position. All products consist basically of a mechanical frame to support the wheelchair, large rear wheels for propelling the wheelchair, and smaller front pivoting casters for turning and steering. Additionally, each of these wheelchairs incorporates a manually operated "tilt in space" feature for patient comfort and positioning.

## Performance Data

The Invacare Action AT II manual wheelchair meets the applicable performance requirements specified in:

- Rehabilitation Engineering Society of North America (RESNA) . Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)
- DIS ISO 7176 (1992) Part 8: Requirements and Test Methods for . Static, Impact and Fatigue Strengths

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Image /page/3/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 a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 JAN

Mr. Edward A. Kroll Director, TQM and Requlatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 44036-2125 Elvria, Ohio

Re: K984447 Action AT II Manual Wheelchair Trade Name: Requlatory Class: I Product Code: IOR Dated: December 11, 1998 December 14, 1998 Received:

Dear Mr. Kroll:

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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 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 requlation may result in requlatory 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 requlations.

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#### Page 2 - Mr. Edward A. Kroll

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 requlation (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.

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

Enclosure

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510(k) Number (if known): K9S4447

Device Name: Action AT II Manual Wheelchair

Indications For Use: To provide mobility to persons limited to a sitting postion.

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use \$\not\$

(Optional Format 1-2-96)

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(Division Sign-Off)
Division of General Restorative Devices K98444
510(k) Number.