QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR

K982989 · Sunrise Medical, Inc. · IOR · Oct 5, 1998 · Physical Medicine

Device Facts

• Record ID: K982989
• Device Name: QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
• Applicant: Sunrise Medical, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as : Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating condition

Device Story

Manual wheelchair providing mobility for physically challenged individuals; features integrated suspension system to improve comfort when traversing uneven terrain or obstacles. Device consists of standard wheelchair components: push handles, armrests, backrest, seat frame, cushion, footrest, and casters. Configurable in various sizes and materials to meet individual user needs. Operated by the user or an assistant; used in home, clinical, or community settings. Suspension mechanism provides mechanical benefit by absorbing shock, potentially increasing user comfort and mobility range.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing to ISO 7176 and ANSI/RESNA Wheelchair Standards (static stability, dimensions, fatigue strength) and a review of complaint/MDR data for manual wheelchairs.

Technological Characteristics

Manual wheelchair; includes suspension system. Materials include standard wheelchair components (frame, cushions, etc.). Tested to ISO 7176 and ANSI/RESNA standards for static stability, dimensions, and fatigue strength.

Indications for Use

Indicated for physically challenged persons of all ages with mobility-limiting conditions, including arthritis, amputation, paraplegia, cerebral palsy, hemiplegia, tetraplegia, quadriplegia, spina bifida, head injury/trauma, muscular dystrophy, multiple sclerosis, polio, or geriatric conditions.

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 GPS by Sunrise Medical
• Action A4 by Invacare Corporation
• Barracuda by Everest & Jennings
• Boing by Colours

Submission Summary (Full Text)

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OCT 5 1998

510k Notification

CONFIDENTIAL

K982989

#### 510(k) SUMMARY OF SAFETY AND EFFICACY 13.0

Sunrise Medical - Mobility Products Division Submitter: 7477 East Dry Creek Parkway Longmont, CO 80503 Phone [phone] Fax [phone]

Rebecca Andersen August 25, 1998 Date:

Name(s) of the device(s):

Suspension Wheelchair Series

### Identification of predicate device(s):

- 1) Ouickie GPS by Sunrise Medical
- 2) Action A4 by Invacare Corporation
- 3) Barracuda by Everest & Jennings
- 4) Boing by Colours

### Description of the device:

Sunrise Medical Suspension Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user. Refer to section 7 for a component diagram of a Suspension chair (figure 1); for nominal dimensions see figure 2.

#### Intended use:

Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as :

Arthritis Amputee

Paraplegic Cerebral Palsy Hemiplegic

Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy

Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating condition

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### Comparison of device characteristics to predicate(s):

The Suspension Wheelchair is a light weight manual chair which is intended to provide mobility based on an individual users' needs and capabilities. It is available in a range of sizes (dimensions) to allow fit to a particular user. The kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort.

#### Testing:

This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include: Static Stability Overall Dimensions Fatigue Strength

## Safety:

An analysis of complaints against Sunrise manual chairs was completed and charted for the period from 4/1/97 through 2/28/98. This analysis was supported by a literature search which was conducted by a third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The data and charts are included as Appendix C. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time.

## Efficacy

Articles are being provided on the use and efficacy of manual wheelchairs.

- "Mobility Technology", by Chris Bale, Home Health Products, January 1996 1)
- 2) "Decisions, Decisions", by Marty Ball, Sports and Spokes, March/April 1997, Vol. 23, No. 2
- 3) "Rolling Revolution", by Arnold Henderson, the Wall Street Journal, September 28, I dddc
- 4) "Performance Pointers", by Marty Ball, Sports and Spokes, July/August 1993, Vol. 19, No. 2

August 25, 1998 Sunrise Medical - Mobility Products Division: Suspension Wheelchair

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- 5) "Technology Solutions", by Mia Moody, Home Health Products, October 1996
- 6) "On the Move", by Andrea Vander Pluym, Home Care, April 1997
- 7) "Chairs, Chairs, Everywhere!", Sports and Spokes, March/April 1994, Vol. 9, No. 6 (author unidentified)
- 8) "Lightweight Chairs", HomeCare Forecast '97, Winter 1997 (author unidentified)

# 510(k) number:

Not assigned at the writing of this summary

## Conclusion:

The Sunrise Medical Suspension Wheelchair Series is substantially equivalent to the predicated devices listed in this 510(k) ;the technology and construction of the Suspension Wheelchair Series does not raise any new issues of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1998

Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. 7477 East Dry Creek Parkway Longmont, Colorado 80503

Re: K982989 Suspension Wheelchair Series Trade Name: Regulatory Class: I Product Code: IOR Dated: August 25, 1998 Received: August 26, 1998

#### Dear Ms. Andersen:

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, Druq, 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. ਸ 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. 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 - Ms. Rebecca Andersen

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.

la 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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# Indications for Use

Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility.

Intended use:

Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as :

- Arthritis Amputee Paraplegic Cerebral Palsy
Hemiplegic

- Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma
Muscular Dystrophy

Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions

510(k) number: Not assigned as of this time

Device name: Suspension Wheelchair Series

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR801.109) #

# Over-the-counter use

(Division Sign-Of Division of General Resto 510(k) Number

August 25, 1998 Sunrise Medical - Mobility Products Division: Suspension Wheelchair

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