(107 days)
No reference devices were used in this submission.
No
The document describes a standard power wheelchair with programmable controls, but there is no mention of AI or ML capabilities.
No.
The device is a power wheelchair intended for mobility, not direct therapeutic treatment.
No
The provided text describes a power wheelchair, which is a mobility device and not a diagnostic device.
No
The device description clearly outlines a physical power wheelchair with a frame, wheels, braking system, actuators, and a control system including a joystick. While it contains software within the drive control units, it is an integral part of a hardware device, not a standalone software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Quickie® and Zippie® power wheelchairs are mobility devices. They are used externally to assist individuals with movement. They do not analyze any biological samples.
- Intended Use: The intended use is to provide mobility to persons restricted to a sitting position. This is a functional purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electrical components of a wheelchair, not on any diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Quickie® and Zippie® power wheelchairs clearly fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.
Product codes
ITI
Device Description
The Quickie® 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.
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
The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.
Intended User / Care Setting
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.
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
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 800-333-4000 Fax: 559-294-2872
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.