← Product Code [ITI](/productcode/ITI) · K160031 # Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) (K160031) _Sunrise Medical (Us), LLC · ITI · Jul 14, 2016 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K160031 ## Device Facts - **Applicant:** Sunrise Medical (Us), LLC - **Product Code:** [ITI](/productcode/ITI.md) - **Decision Date:** Jul 14, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3860 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Pediatric ## 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. ## Device Story Battery-powered, user-controlled electric wheelchairs; Quickie Pulse for medium/large individuals; Zippie ZM-310 for smaller individuals/children. Optional Bluetooth Mouse Module (BMM) added to control bus; allows users to utilize existing wheelchair joystick/input device to control pointer functions on external Bluetooth-enabled devices (e.g., tablets/PCs). Feature only active when wheelchair is stationary. Used in homes, healthcare facilities, and outdoors. Provides convenience for disabled users to interact with external electronics without leaving the chair. BMM operates in 2.4-2.485 GHz ISM band; frequency-hopping spread-spectrum. Safety ensured by ensuring BMM operation does not interfere with wheelchair braking or electronic control systems. ## Clinical Evidence No clinical or animal data provided. Substantial equivalence supported by bench testing, including electromagnetic compatibility (EMC) testing per ANSI/RESNA WC2 standards (extended to 3.0 GHz) and operational verification of the wireless pointer function. ## Technological Characteristics Battery-powered electric wheelchair; BMM adds Bluetooth 2.4-2.485 GHz transmitter (Class 1, 100mW max, frequency-hopping). Connectivity: Bluetooth wireless to external devices. EMC tested to ANSI/RESNA WC2. Software: Embedded firmware for BMM pointer control logic. ## Regulatory 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 Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC & SC) ([K142457](/device/K142457.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 14, 2016 Sunrise Medical (US) LLC Laurie Roberts Director, Regulatory Affairs 2842 Business Park Av Fresno, California 93727 Re: K160031 Trade/Device Name: Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 9, 2016 Received: June 9, 2016 Dear Laurie 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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" (21 CFR 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, # Michael J哥offmann -A 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K160031 Device Name Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY ## Submitter | Company | Sunrise Medical (US) LLC
2842 Business Park Avenue
Fresno, CA 93727
Tel: 800-333-4000
Fax: 559-294-2872 | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Laurie Roberts, MS, RAC
Director, Regulatory Affairs | | Device | | | Trade name | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie
ZM-310 (Models BC, SC) | | Class name | Wheelchair, powered (21 CFR 890.3860) | | Product code | ITI | | Class | 2 | | Predicate | | | Devices | Quickie Pulse: Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC and Zippie ZM-
310: Models BC & SC; legally marketed per 510(k): K142457 | | Recalls | These predicate devices have not been subject to a design-related recall. | | Device Description | | | Overview | Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric
wheelchairs. All models of these wheelchairs will be offered with an optional
wireless pointer control feature. | | Wireless
pointer
control
feature | This option entails adding a Bluetooth Mouse Module (BMM)-a small
Bluetooth transmitter-mounted to the chair and wired into its control bus. | | | With BMM in place, the wheelchair's controller can then use the pointer-
control feature built into the BMM hardware and software. | | | Pointer control can only be activated when the wheelchair is stationary and
not actively performing wheelchair functions. | | Purpose of
feature | The BMM lets users use the chair's joystick, or other input device, to control
the pointer functions of Bluetooth-enabled devices (such as personal or
tablet computers) while the chair is not in operation. | | Model
distinctions | The wireless pointer control feature will be offered on all models of the
Quickie Pulse and Zippie ZM-310 series chairs.

Technologically, all of these chair designs are identical. Model designations
relate to widths and heights of their seats and various components: such as
seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children | | Use
environment | These chairs, along with the BMM, are meant for use in healthcare facilities,
in the home, outdoors, and other places of individual activity for the disabled. | Continued on next page {4}------------------------------------------------ ### Device Description (continued) #### 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. | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature fact | The Indications for Use for the Quickie and Zippie power wheelchairs with wireless pointer control are identical to those for the chairs that do not have the feature. The feature is strictly an add-on for the convenience of the users. | ## Technological Characteristics and Comparison | Design | Technological characteristics—design, materials, motors, electronics, power source, etc.—are identical to the predicate devices with the exception of the addition of the BMM. | |------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | BMM option | By adding the BMM, wireless pointer control can be engaged.
The BMM adds The ability to use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled electronic devices Some extra wiring to the electronic system raising the issue of continued electromagnetic compatibility for the chairs A low-power radio-frequency transmitter in the 2 to 2.5 GHz Bluetooth frequency range raising the issue of electromagnetic emissions interfering with chair brake function (chair is not in motion at the time of transmission but may be braking to hold chair on an incline) | {5}------------------------------------------------ ### Technological Characteristics and Comparison (continued) | Parameters | K160031 (subject device) | K142457 (predicate device) | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Models | Quickie Pulse® (Models: 6BC,
6SC, 6CC, 5BC, 5CC, 6MPC)
and Zippie® ZM-310 (Models:
BC & SC) | Same | | Intended Use | To provide mobility to persons
limited to a seating position
that have the capability of
operating a powered
wheelchair | Same | | 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. | Same | | Bluetooth feature available | YES
Bluetooth technology operates
in unlicensed industrial,
scientific and medical (ISM)
band at 2.4 to 2.485 GHz,
using a spread-spectrum,
frequency-hopping, full-duplex
signal at a nominal rate of
1600 hops/sec.
Class 1 output - used
primarily in industrial use
cases - 100 meters Power is
100mW max for Class 1 | NO | | Other technical features | Same | Same | | Evaluation methods | Same | Same | {6}------------------------------------------------ #### Performance Data The following non-clinical performance data were provided in support of the substantial equivalence determination. | Performance | Operational performance of wireless pointer function without detriment to
wheelchair function or features
Chair's electrical braking continued to hold on a maximum slope during
BMM operation Wireless pointer function properly executed on typical external Bluetooth-
enabled electronic device from wheelchair inputs | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EMC | Electromagnetic compatibility testing carried out to cover functional
verification and device performance to ANSI/RESNA WC2 testing plus over
extended frequency range through 3.0 GHz with BMM mounted in its
closest proximity (worst-case) position to the wheelchair controller
demonstrated Immunity of total chair system with BMM mounted and connected No effect on chair during BMM activation | | Software
qualification | Wireless pointer function demonstrated while chair not in operation,
qualifying the BMM and its software by successful device performance. | No animal or clinical data necessary to demonstrate the performance of this option. #### Conclusion The performance data support the electromagnetic compatibility of the BMM to the Quickie and Zippie power wheelchairs and their operation. The operational verification and validation of the wireless pointer control feature demonstrate that the feature performs as intended in the specified use conditions. Thus, the optional feature added to these chairs produce comparable results to the predicate devices for the same intended use. The devices are substantially equivalent to their predicates. --- **Source:** [https://fda-staging.innolitics.com/device/K160031](https://fda-staging.innolitics.com/device/K160031) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com