QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300

• K Number: K981462
• Device Name: QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
• Manufacturer: SUNRISE MEDICAL, INC.
• Date Cleared: 1998-11-06 ( 197 days)
• Product Code: ITI
• Regulation Number: 890.3860

Intended Use

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

Device Description

The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair. The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries. Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard power wheelchair with a joystick control and basic motor/brake functionality. There is no mention of adaptive learning, pattern recognition, or any other characteristics typically associated with AI/ML.

Therapeutic

No
The device is a power wheelchair, described as a means of mobility for physically challenged persons, not directly treating a disease or condition.

Diagnostic

No

The device description clearly states it is a power wheelchair, designed to provide mobility for physically challenged persons, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components including a motor, brakes, batteries, joystick, and a rigid frame, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to provide mobility for physically challenged persons. This is a mechanical function, not a diagnostic one.
• Device Description: The description details the components and operation of a power wheelchair. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
• Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
• Performance Studies: The performance studies focus on the physical and electrical performance of the wheelchair (stability, brakes, speed, EMC, etc.), not on diagnostic accuracy.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This power wheelchair does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

ITI

Device Description

The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair.

The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries.

Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.

If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

This device has been tested to both ISO7176 and ANSURESNA Wheelchair Standards. They include:

• Static Stability Dynamic Stability Effectiveness of Brakes Energy consumption Overall Dimensions Maximum Speed acceleration and retardation Static Impact Fatigue Strength Climatic Test Obstacle Climbing Ability Testing of Power and Control System EMC Testing
  We have also tested to the Proposed:
• Addition to ANSURESNA W/C 14 Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94
• ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

6 1998 NOV

K981462

510(k) SUMMARY OF SAFETY AND EFFICACY 13.0

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

Date: November 5, 1998

Name(s) of the device(s):

S-525 Power Wheelchair

Identification of predicate device(s):

• 1. Quickie P190 by Sunrise Medical
• 2. Quickie P120 by Sunrise Medical
• 3. Sabre by Everest & Jennings
• 4. Ranger II by Invacare Corporation

Description of the device:

The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair.

The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries.

Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.

If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

Intended use:

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

1

Comparison of device characteristics to predicate(s):

This device has similar technological characteristics as the predicated devices. They all use steel and aluminum in their frame and components, and standard foams and covers for the slings and backs. Microprocessors are typically used with a programmable controller, and the rider controls the chair using a joystick or other equivalent command mode. Motors use permanent magnets, employing 24 volt D.C., with rechargeable deep cycle batteries for an energy source. The operating speeds and maneuverability are substantially equivalent, and recommended for indoor or moderate outdoor use. The standard accessories and components are common to all power wheel chair lines.

Testing:

This device has been tested to both ISO7176 and ANSURESNA Wheelchair Standards. They include:

• Static Stability Dynamic Stability Effectiveness of Brakes Energy consumption Overall Dimensions Maximum Speed acceleration and retardation Static Impact Fatigue Strength Climatic Test Obstacle Climbing Ability Testing of Power and Control System EMC Testing
  We have also tested to the Proposed:

Addition to ANSURESNA W/C 14 Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94

• ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters.

2

Safety:

An analysis of complaints against Sunrise power chairs was completed and charted. 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. Subsequent complaints against Sunrise are presented in a chart entitled "Total Sunrise Medical Power Product Complaints". The data and charts are included as The analysis demonstrated common issues across all manufacturer product Attachment 13 - A. 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 power wheelchairs.

• "Power Wheelchair Comparison", Ian Denison, 14th International Seating 1) Symposium Proceedings, pp. 113 - 116, February 1998.
• 2. "Front, Back or in the Middle: Understanding Mid-Wheel Drive", Mark Greig, Sunrise Horizons, Vol 1, Number 4, pp. 6 - 7, February 1998.
• 3. "Dynamic Wheelchair Stability: Reliability of an Ordinal Scale", R. L. Kirby, D. A. MacLeod, R. E. Duggan, et. al., Proceedings of RESNA '97, pp. 237-239.
• 4. "When Wheelchairs Tip backwards Beyond Their Stability Limits", R. L. Kirby, M. DiPersio, and D. A. MacLeod, Proceedings of RESNA '96, pp. 180 - 182.
• 5. "Effect on Wheelchair Stability and Maneuverability of Varying the Position of the rear Antitip Device: A Theoretical Model", R. L. Kirby, A. V. Thoren, B. D. Ashton, and S. A. Ackroyd-Stolarz, Proceedings of RESNA '93, pp. 313 - 315.

510(k) number: K981462

Conclusion:

The Quickie S-525 (a.k.a. P190R) Power Wheelchair is substantially equivalent to the predicated devices listed in this 510(k); the technology and construction of the S - 525 does not raise any new issues of safety and effectiveness.

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

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

Re: K981462 S-525 Power Wheelchair Trade Name: Requlatory Class: II Product Code: ITI Dated: August 7, 1998 Received: August 10, 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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 requlation (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 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 requlations.

4

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 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,

Cella 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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ﻣﺮ: ﻣﺰﻳﺪ ﺍ

Indications for Use

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

510(k) number: K981462

Device name: S-525

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR801.109)

ਲ Over-the-counter use

Acolly

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