Quickie, Zippie

K142457 · Sunrise Medical (Us), LLC · ITI · Dec 18, 2014 · Physical Medicine

Device Facts

• Record ID: K142457
• Device Name: Quickie, Zippie
• Applicant: Sunrise Medical (Us), LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.

Device Story

Battery-operated center-wheel-drive power wheelchairs; designed for indoor use in care facilities and private residences. Input: user manipulation of joystick controller. Transformation: controller processes joystick input to regulate motors, brakes, and drive wheels. Output: motorized mobility. Operation: user-controlled via joystick; optional attendant control available. Programmable R-net drive controller manages speed and direction. Safety: automatic braking system engages when joystick is in neutral or if electrical system fails. Benefits: provides independent mobility for individuals unable to walk.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing, including electrical safety, electromagnetic compatibility (EMC), and mechanical functional verification according to ANSI/RESNA wheelchair standards. Biocompatibility confirmed by material equivalence to predicate.

Technological Characteristics

Center-wheel-drive; steel and aluminum welded frame; standard foam/fabric seating. Energy: battery-powered. Control: programmable electronic controller/joystick (R-net system). Braking: automatic/electric. Connectivity: programmable controller. Standards: ANSI/RESNA.

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance, including pediatric patients or those of smaller stature for the Zippie® variant.

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 Rhapsody, MWD Series II Power Wheelchair (K062701)
• Quickie Rhythm Power Wheelchair (K083249)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2014

Sunrise Medical (US) LLC Laurie Roberts Director, Regulatory Affairs 2842 Business Park Avenue Fresno, CA 93727

Re: K142457

Trade/Device Name: Quickie® Plus Powered Wheelchairs: 6BC, 6SC, 6CC, 5CC, 6MPC and Zippie® Powered Wheelchairs: ZM-310 BC & ZM-310 SC Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 12, 2014 Received: November 17, 2014

Dear Ms. Roberts:

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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K142457

### Device Name

Quickie® Plus Powered Wheelchairs: 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC Zippie® Powered Wheelchairs: ZM-310 BC & ZM-310 SC

### Indications for Use (Describe)

Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Sunrise Medical. The logo consists of a stylized sun on the left, with the word "SUNRISE" in orange letters to the right of the sun. Below the word "SUNRISE" is the word "MEDICAL" in gray letters. The logo is simple and modern, and the colors are bright and cheerful.

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

#### I. SUBMITTER

Sunrise Medical (US) LLC 2842 Business Park Avenue Fresno, CA 93727

Phone: [phone] Fax: [phone]

Contact Person: Laurie Roberts, MS, RAC Date Prepared: August 29, 2014

#### II. DEVICE

Name of Devices: Ouickie® Pulse 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC Zippie® ZM-310 BC & ZM-310 SC Common or Usual Name: powered wheelchair Classification Name: Wheelchair, Powered (21 CFR 890.3860) Regulatory Class: II Product Code: ITI

#### PREDICATE DEVICE III.

Quickie Rhapsody, MWD Series II Power Wheelchair. K062701 (Primary Predicate) Quickie Rhythm Power Wheelchair (Controller Change), K083249 (Secondary Predicate)

No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

The Ouickie® and Zippie® power wheelchairs are designed for indoor use at care facilities and private residences. The pediatric variant of the Quickie® Pulse 6, branded the Zippie® ZM-310, is intended to provide a slightly broader range of seating size options for people that are smaller in stature-including children. It varies from the Quickie® Pulse 6 only in having smaller seat options.

#### V. INDICATIONS FOR USE

Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The

www.SunriseMedical.com 800.333.4000

²⁸⁴² Business Park Avenue · Fresno, CA 93727-1328 · USA

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Image /page/4/Picture/1 description: The image shows the logo for Sunrise Medical. The logo features a stylized sun graphic on the left, with the word "SUNRISE" in orange letters to the right of the sun. Below "SUNRISE" is the word "MEDICAL" in gray letters. The sun graphic is a gradient of orange and yellow, with gray lines at the bottom.

Zippie® power wheelchairs are specifically for people who are slightly smaller in statureincluding children.

The wording of the Indications for Use statement has been modified to align it more closely with the wording of 21 CFR 890.3860 (Powered Wheelchair) but the intent is the same as for the predicate.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The Quickie® and Zippie® power wheelchairs are center-wheel-drive battery-powered wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring.

The wheelchairs have steel and aluminum frame structure which is welded and utilizes standard foams and covers for the seat.

The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair.

Actuators allow the seating to be adjusted to suit the user and activity.

A control system (i.e. controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant control. The optional drive controller R-net system provides further features. The controller is fully programmable.

Technological characteristics are the same as for the predicate devices.

### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility Testing

The materials used for the Quickie® and Zippie® power wheelchair components which have patient contact are the same as those used in the primary predicate device. Therefore, further testing was not required.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and electromagnetic compatibility testing of Quickie® and Zippie® power wheelchairs was carried out to cover functional verification and device performance. Testing established correct functionality of the wheelchairs according to the relevant ANSVRESNA Wheelchair standards.

### Software Verification and Validation Testing

The Quickie® and Zippie® power wheelchairs contain software within the drive control units. The software in the two products is identical. A Letter of Authorization was provided by the supplier of the drive controller units in order access the medical device Master File for the controllers.

### Mechanical and acoustic Testing

Mechanical testing of Quickie® and Zippie® power wheelchairs was carried out to cover functional

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Image /page/5/Picture/1 description: The image shows the logo for Sunrise Medical. The logo features a stylized sun graphic on the left, with the word "SUNRISE" in orange text to the right of the sun. Below "SUNRISE" is the word "MEDICAL" in gray text.

verification and device performance. Testing established correct functionality of the wheelchairs according to the relevant ANSI/RESNA Wheelchair standards. No acoustic testing was required to demonstrate device safety and effectiveness of the wheelchair.

### Animal Study

Animal performance testing was not required to demonstrate device safety and effectiveness of the wheelchair.

### Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the wheelchair.

### VIII. CONCLUSIONS

Testing carried out for the Quickie® and Zippie® power wheelchairs indicates that they meet design and performance functional requirements and function equivalently to the predicate devices meet the relevant ANSI/RESNA Wheelchair standards.

This information indicates that the Quickie® and Zippie® power wheelchairs are equivalent to the predicate devices in terms of device safety and effectiveness.