Frontier Series Power Wheelchairs

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November 19, 2021 Magic Mobility % Matthieu Kirkland Regulatory Specialist Acknowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, California 92110 Re: K213090 Trade/Device Name: Frontier Series Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 20, 2021 Received: September 24, 2021 Dear Matthieu Kirkland: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Heather L. Dean -S Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213090 Device Name Frontier Series Power Wheelchairs Indications for Use (Describe) The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. | 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 #### DATE PREPARED September 20, 2021 #### MANUFACTURER AND 510(k) OWNER Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Jill McKechnie, General Manager #### REPRESENTATIVE/CONSULTANT Matthieu Kirkland, M.S. Allison Komiyama, Ph.D., RAC AcKnowledge Regulatory Strategies, LLC Telephone: Email: mkirkland@acknowledge-rs.com Website: https://www.acknowledge-rs.com/ #### DEVICE INFORMATION | Proprietary Name/Trade Name: | Frontier Series Power Wheelchairs | |------------------------------|-------------------------------------------------------| | Common Name: | Wheelchair, Powered | | Regulation Number: | 21 CFR 890.3860 | | Class: | Class II | | Product Code: | ITI | | Premarket Review: | Neuromodulation and Physical Medicine Devices (DHT5B) | | Review Panel: | Physical Medicine | #### PREDICATE DEVICE IDENTIFICATION The Frontier Series Power Wheelchairs are substantially equivalent to the following predicates: | 510(k) Number | Predicate Device Name / Manufacturer | Predicate Relationship | |---------------|------------------------------------------------------------------------|-------------------------------| | K030783 | Frontier Power Wheelchair/ Innovation In Motion | Primary Predicate<br>Device | | K142457 | Quickie® and Zippie® Powered Wheelchairs /<br>Sunrise Medical (US) LLC | Secondary Predicate<br>Device | | K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | Reference Device | {4}------------------------------------------------ #### DEVICE DESCRIPTION The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position. The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). The Frontier Series Power Wheelchairs include the following accessories: - Extra spreader bar - Slide in table - Lights ● - Luggage rack ● - Accessory charger ● - Posture belt - Roho cushion - Jay cushion - MPS push rail - MPS peg push handle - Scooter stopper - Retractable docking pin - Fold forward kit ● #### INTENDED USE Magic Mobility power chairs are designed for the exclusive use of people (adults and children) who are unable to walk or have limited mobility and have the cognitive, physical and visual ability to control the vehicle safety. The Magic Mobility Frontier series is intended to be selfpropelled on a range of surfaces. The All-Terrain tires can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). {5}------------------------------------------------ #### INDICATIONS FOR USE The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Magic Mobility believes that the Frontier Series Power Wheelchairs are substantially equivalent to the predicate devices based on the information summarized here: The subject devices have a similar design and dimensions and uses similar or identical materials as the devices cleared in K030783 and K142457. The subject devices have intended use and similar technological characteristics (i.e., base technology and OEM joystick control) to the devices cleared in K030783, K142457, and K172384. The subject devices have the same intended use environment, including off road capabilities, as the device cleared in K030783. The subject devices use the same software as the device cleared in K172384. The Frontier Series Power Wheelchairs have undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no anti-pitch mechanism) do not affect safety and effectiveness when compared to the predicate and reference devices. {6}------------------------------------------------ | | Subject Devices | Predicate Device | Predicate Device | Reference Device | Statement of Equivalence | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | | Magic Mobility | Innovation in Motion | Sunrise Medical (US) LLC | Sunrise Medical (US) LLC | | | Indications for Use | Frontier Series Power<br>Wheelchairs | Frontier Power Wheelchair | Quickie® and Zippie® Powered<br>Wheelchairs | Quickie® Q700-UP M | Substantially equivalent to<br>predicate devices. | | | The Frontier Series Power<br>Wheelchairs are battery-<br>operated devices with<br>wheels that are intended<br>for medical purposes to<br>provide mobility to<br>persons restricted to a<br>sitting position who have<br>the capability of<br>operating a power<br>wheelchair. | K030783<br>The intended use of the<br>Frontier Power wheelchair<br>is to provide mobility to<br>persons limited to a sitting<br>position, who have the<br>capability of operating a<br>power wheelchair. | K142457<br>Quickie® and Zippie® power<br>wheelchairs are battery-operated<br>devices with wheels that are<br>intended for medical purposes to<br>provide mobility to persons<br>restricted to a sitting position. The<br>Zippie® power wheelchairs are<br>specifically for people who are<br>slightly smaller in stature—<br>including children. | K172384<br>The Sunrise Medical<br>Quickie® Q700-UP M<br>power wheelchairs<br>are battery operated<br>devices, that are<br>indicated for medical<br>purposes to provide<br>mobility and<br>repositioning of the<br>user, including a<br>stand-up feature. | | | Product Codes /<br>Regulation<br>Number | ITI/21 CFR 890.3860 | ITI/21 CFR 890.3860 | ITI/21 CFR 890.3860 | IPL/21 CFR<br>890.3900 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Regulation<br>Description | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Technical Specifications | | | | | | | General<br>Maximum User<br>Weight (lbs) | Frontier V4 FWD: 400<br>Frontier V4 RWD: 400<br>Frontier V6: 400<br>Frontier V6 C73:400 | 400 | 300 | 265 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Storage<br>Temperature<br>(°C) | -40 to 70 | -40 to 70 | -40 to 70 | -40 to 70 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Location for<br>Use | Indoors and outdoors<br>including care facilities,<br>and residences | Indoors and outdoors<br>including care facilities, and<br>residences | Indoors and outdoors including<br>care facilities, and residences | Indoors and<br>outdoors including<br>care facilities, and<br>residences | Identical to the primary predicate.<br>No impact on safety and effectiveness. | | Frame Material | Steel | Steel | Steel and aluminum | Steel and aluminum | Identical to the primary predicate. | | Subject Devices | Predicate Device | Predicate Device | Reference Device | Statement of Equivalence | | | Magic Mobility<br>Frontier Series Power<br>Wheelchairs | Innovation in Motion<br>Frontier Power Wheelchair | Sunrise Medical (US) LLC<br>Quickie® and Zippie® Powered<br>Wheelchairs | Sunrise Medical (US)<br>LLC<br>Quickie® Q700-UP M | | | | | K030783 | K142457 | K172384 | | | | Biocompatibility | Uses materials common to<br>many wheelchairs | Uses materials common to many<br>wheelchairs | Uses materials<br>common to many<br>wheelchairs | No impact on safety and<br>effectiveness.<br>Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | | Base<br>Overall<br>Dimensions<br>(length by<br>width; inches) | 43.34 x 28 | 24"x34" | 25"x36" | Substantially equivalent to the<br>predicate and reference devices.<br>No impact on safety and<br>effectiveness. | | | Frontier V4 FWD AT tires:<br>39.2 x28<br>Frontier V4 FWD Hybrid<br>tires: 39.2 x 26.3<br>Frontier V4 RWD AT tires:<br>36.6 x 28<br>Frontier V4 RWD Hybrid<br>tires: 36.6 x 26.3<br>Frontier V6 AT tires:<br>42 x 28<br>Frontier V6 Hybrid tires:<br>42 x 27.5<br>Frontier V6 C73:<br>39.5 x 25.5 | | | | | | | Rolling Base<br>Weight (lbs) | 260 (with batteries) | 130 | 152 | Substantially equivalent to the<br>predicate device. No impact on<br>safety and effectiveness. | | | Power Source | Batteries | Batteries | Batteries | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | {7}------------------------------------------------ {8}------------------------------------------------ | Subject Devices<br>Magic Mobility | Predicate Device<br>Innovation in Motion<br>Frontier Series Power<br>Wheelchairs | Predicate Device<br>Sunrise Medical (US) LLC<br>Quickie® and Zippie® Powered<br>Wheelchairs | Reference Device<br>Sunrise Medical (US) LLC | Statement of Equivalence | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------| | | Frontier Power Wheelchair | | Quickie® Q700-UP M | | | Battery Details | Two (2) 73 Ahr | K142457<br>22 NF, sealed lead acid or gel cell | K172384<br>24V (2x12V)/73<br>Ah/20h | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Castor Wheel<br>Size (inches) | 8.25 x 2.5 | Unknown | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Range (miles) | 15-20 | Unknown | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Anti-pitch<br>Mechanism for<br>Climbing | None | Additional anti-pitch lock out | Additional anti-pitch<br>lock out | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Lift Range<br>(inches) | 0-12 | 0-12 | 0-12 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Tilt Range<br>(degrees) | 0-50 | 0-50 | 0-50 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Recline Range<br>(degrees) | 0-170 | 0-170 | 0-172 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Suspension | Independent drive wheel<br>suspension with shock<br>absorber on pivoting<br>swing arm and<br>articulated castors to<br>ensure all wheels<br>maintain adhesion at all<br>surface angles | Independent drive wheel<br>suspension with shock<br>absorber on pivoting swing<br>arm and articulated castors<br>to ensure all wheels<br>maintain adhesion at all<br>surface angles | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Maximum<br>speed (mm) | 6 | 6 | 6 (with an option of<br>8) | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Subject Devices | Predicate Device<br>Innovation in Motion | Predicate Device<br>Sunrise Medical (US) LLC | Reference Device<br>Sunrise Medical (US)<br>LLC | Statement of Equivalence | | Magic Mobility<br>Frontier Series Power<br>Wheelchairs | Frontier Power Wheelchair | Quickie® and Zippie® Powered<br>Wheelchairs | Quickie® Q700-UP M | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | | K030783 | K142457 | K172384 | | | Minimum<br>Braking<br>Distance at<br>Maximum<br>Speed (meters) | 1.8 | Unknown | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | User Controller | Joystick and hand control<br>buttons | Joystick and hand control buttons | Joystick and hand<br>control buttons | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Joystick Mount | Joystick and hand control<br>buttons | Fixed mount, height adjustable,<br>swing-away | Fixed mount, height<br>adjustable, swing-<br>away | Identical to the predicate and<br>reference devices. No impact on<br>safety and effectiveness. | | Software | R-Net from PGDT | VR2 from PGDT | R-Net from PGDT | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Seat/Armrest/Footrest | | | | | | Seat Height<br>(minimum,<br>inches) | 17.1 | 16.2 | 16.2" | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Seat Width<br>(inches) | 16-24 | 12-24 | 16-22 | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Armrest | Height adjustable,<br>Removable, flip up option | Unknown | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | | Footrest | Rigid footplate, flip up<br>nylon | Unknown | Unknown | Identical to the primary predicate.<br>No impact on safety and<br>effectiveness. | {9}------------------------------------------------ {10}------------------------------------------------ ### SUMMARY OF NON-CLINICAL TESTING The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards. The results of these tests indicate that the Frontier Series Power Wheelchairs are substantially equivalent to the predicate devices. #### PERFORMANCE - Static stability (per ISO 7176-1) ● - Dynamic stability (per ISO 7176-2) ● - Effectiveness of brakes (per ISO 7176-3) - Energy consumption (per ISO 7176-4) ● - Dimensions, mass, and maneuvering space (per ISO 7176-5) - Maximum speed, acceleration, and deceleration (per ISO 7176-6) - Measurement of seat and wheel dimensions (per ISO 7176-7) - Static, impact, and fatigue (per ISO 7176-8) - Climatic test (per ISO 7176-9) - Obstacle climbing (per ISO 7176-10) - . Test dummies (per ISO 7176-11) - Power and control systems for power wheelchairs (per ISO 7176-14) - Documentation and labeling (per ISO 7176-15) ● - Resistance to ignition (per ISO 7176-16) - Dynamic Test (per ISO 71716-19) - Vocabulary (per ISO 7176-26) # EMC AND ELECTRICAL SAFETY - EMC testing (per ISO 7176-21) ● - Batteries and chargers per (per ISO 7176-25) # BIOCOMPATIBILITY - Evaluation and testing within a risk management process (per ISO 10993-1) ● - . In vitro cytotoxicity (per ISO 10993-5) The materials used in the subject devices are identical composition, formulation processing, sterilization, and geometry as the materials found in the devices cleared in K030783, K142457, and K172384 . Furthermore, the Frontier Series Power Wheelchairs have the same nature of tissue contact and contact duration as the predicate and reference devices. Therefore, based on previous use and the cytotoxicity testing conducted, the subject devices are considered to have met the requirements of ISO 10993-1 and FDA's Guidance for Industry and Food and Drug Administration Staff – Use of International ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." {11}------------------------------------------------ #### SOFTWARE - Software life cycle process (per IEC 62304) ## CONCLUSION Based on the testing performed (including wheelchair dynamic testing and flammability) it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Frontier Series Power Wheelchairs are assessed to be substantially equivalent to the predicate devices.