QUICKIE G SERIES, MODEL G-424

K983677 · Sunrise Medical, Inc. · ITI · Nov 6, 1998 · Physical Medicine

Device Facts

• Record ID: K983677
• Device Name: QUICKIE G SERIES, MODEL G-424
• Applicant: Sunrise Medical, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Quickie powered 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 conditions

Device Story

G-424 is a mid-wheel drive, moderate-duty power wheelchair; provides mobility for physically challenged users. Components include steel frame, suspension, modular seat, armrests, footrest, casters, drive wheels, batteries, and Penny & Giles Pilot controller. Operated by user via joystick. Device transforms electrical power from batteries into mechanical motion via motors and brakes. Used in various environments for daily mobility. Provides improved aesthetics via thermoformed plastic covers. Benefits patient by restoring independent mobility.

Clinical Evidence

No clinical data. Bench testing only. Device tested to ISO 7176 and ANSI/RESNA Wheelchair Standards, including static/dynamic stability, brake effectiveness, energy consumption, dimensions, speed/acceleration/retardation, static impact, fatigue strength, climatic testing, obstacle climbing, power/control system testing, and EMC testing. All tests passed.

Technological Characteristics

Mid-wheel drive power wheelchair. Materials: steel frame, thermoformed plastic covers. Energy source: battery-powered electric motors. Control: Penny & Giles Pilot controller. Connectivity: None. Sterilization: N/A. Standards: ISO 7176, ANSI/RESNA.

Indications for Use

Indicated for physically challenged persons of all ages requiring mobility assistance due to conditions including arthritis, amputation, paraplegia, cerebral palsy, hemiplegia, tetraplegia/quadriplegia, spina bifida, head injury/trauma, muscular dystrophy, multiple sclerosis, polio, or geriatric/other immobilizing conditions.

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

• Quickie P200 by Sunrise Medical
• Quickie P120 by Sunrise Medical

Submission Summary (Full Text)

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### 6 1998 NOV

CONFIDENTIAL

983677

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

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

Rebecca Andersen October 13, 1998 Date:

Name(s) of the device(s): Identification of predicate device(s): 1) Quickie P200 by Sunrise Medical

2) Quickie P120 by Sunrise Medical

G-424 Power wheelchair Modification to a Sunrise Device

## Description of the device:

The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller.

The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries

Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding a plastic thermoformed molded cover.

### Intended use:

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

| Arthritis | Tetraplegic |
|----------------|-----------------------|
| Amputee | Quadriplegic |
| Paraplegic | Spina Bifida |
| Cerebral Palsy | Head Injury or Trauma |
| Hemiplegic | Muscular Dystrophy |

Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating conditions

Comparison of device characteristics to predicate(s):

The proposed device modifications combine technological characteristics from two Sunrise predicate devices.

Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding plastic thermoformed molding covers.

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# Testing:

This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include:

| Static Stability | Pass |
|--------------------------------------------|------|
| Dynamic Stability | Pass |
| Effectiveness of Brakes | Pass |
| Energy consumption | Pass |
| Overall Dimensions | Pass |
| Maximum Speed acceleration and retardation | Pass |
| Static Impact | Pass |
| Fatigue Strength | Pass |
| Climatic Test | Pass |
| Obstacle Climbing Ability | Pass |
| Testing of Power and Control System | Pass |
| EMC Testing | Pass |

# Safety:

The Quickie G-424 Power Wheelchair is substantially equivalent to the existing Sunrise Medical predicate devices. The modifications to this device have been validated using appropriate Design Controls and therefore have been demonstrated to be "non significant" with respect to safety or effectivenes.

i

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6 1998 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K983677 Re: G-424 Power Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: October 13, 1998 Received: October 19, 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, 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. 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 action. In addition, FDA may publish further announcements 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. 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., M

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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## Indications for Use

Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility

This includes conditions in all ages such as:

| Arthritis | Head Injury or Trauma |
|----------------------------|---------------------------------------------------|
| Amputee | Muscular Dystrophy |
| Paraplegic | Multiple Sclerosis |
| Cerebral Palsy | Polio |
| Hemiplegic | Geriatric Conditions |
| Tetraplegic (Quadraplegic) | And other immobilizing or debilitating conditions |
| Spina Bifida | |

A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249

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

Device name: G-424

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

Prescription use (per 21 CFR801.109) 0

0 Over-the-counter use

fcoello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ***_***__K983677

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