Magic 360 Power Wheelchair

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March 17, 2021 Magic Mobility % Michelle Rubin-Onur Senior Regulatory Specialist AcKnowlegde Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, California 92110 Re: K203083 Trade/Device Name: Magic 360 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 17, 2020 Received: December 18, 2020 Dear Michelle Rubin-Onur: 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/cfpmp/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. 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 {1}------------------------------------------------ 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 (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 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) K203083 Device Name Magic 360 Power Wheelchair Indications for Use (Describe) The Magic 360 Power Wheelchair is a battery-operated device with wheels that is 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. 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The letters are black, and there is a trademark symbol in the bottom right corner. # 510(k) Summary K203083 #### DATE PREPARED March 17, 2020 ## MANUFACTURER AND 510(k) OWNER Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Alex Suen, Quality Assurance and Regulatory Affairs Manager ## REPRESENTATIVE/CONSULTANT Michelle Rubin-Onur, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: Email: mrubin@acknowledge-rs.com; akomiyama@acknowledge-rs.com ### DEVICE INFORMATION | Proprietary Name/Trade Name: | Magic 360 Power Wheelchair | |------------------------------|-------------------------------------------------------| | 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 Magic 360 Power Wheelchair is substantially equivalent to the following predicates: | 510(k) Number | Predicate Device Name / Manufacturer | Predicate Relationship | |---------------|----------------------------------------------------------------------------------------------------|------------------------| | K142457 | Quickie® and Zippie® Powered Wheelchairs /<br>Sunrise Medical (US) LLC | Primary Predicate | | K181908 | Action Trackchair: Eagle 16, Eagle 18, Eagle 20,<br>Eagle 22, Eagle 24 / Action Manufacturing Inc. | Secondary Predicate | | K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | Reference Device | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the "ma" in red and the "gic" in black. The word "Mobility" is written in a cursive font below the word "magic". The logo is simple and modern. ### DEVICE DESCRIPTION The Magic 360 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position. The Magic 360 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e. concrete, asphalt, indoor flooring, gravel, grass, and bark). The subject device has two seat options: MPS and rehab. The rehab seat option has more built-in adjustments (i.e., width and depth adjustments) and allows for aftermarket cushions. All the wheelchairs include the same power seating options including lift, tilt, recline, and leg elevation to ensure the user to find a position that is comfortable. The Magic 360 Power Wheelchair includes 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 Please note, the fold forward kit is an accessory which allows the user to fold the wheelchair and put the wheelchair in a car. To fold the wheelchair the user pulls the red release handle located at the back of the Magic 360 Power Wheelchair. To unfold the wheelchair the user pulls the frame back into place using the armrests. ## 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. Users must have the cognitive, physical and visual ability to control the vehicle safely. The Magic Mobility Magic 360 power chair is intended to be self-propelled on a range of surfaces that vary depending on the configuration of the chair: Urban, Off-Road, and Crossover. The Urban configuration with narrow tires is better suited for tighter spaces and harder surfaces such as all traditional interior surfaces {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the top half of the letters in red and the bottom half in black. Below the word "magic" is the word "Mobility" written in a cursive font. The letters "TM" are in the bottom right corner of the image. (e.g., carpet, laminate and tile flooring) and hard outdoor surfaces (e.g., concrete, asphalt, and tarmac). The Urban configurations are not designed for unstable, inconsistent, or loose surfaces such as grass, loose stone, sand, or cobblestone. The Off-Road configuration with wider tires is physically larger requiring more space to maneuver, it is well suited on surfaces such as grass, loose stone, sand, or cobblestone. The Crossover is a compromise between the Urban and Off-Road configurations. ## INDICATIONS FOR USE The Magic 360 Power Wheelchair is a battery-operated device with wheels that is 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 Magic 360 Power Wheelchair is substantially equivalent to the predicate devices based on the information summarized here: The subject device has a similar design and dimensions and uses similar or identical materials as the devices cleared in K142457. The subject devices have intended use and similar technological characteristics (e.g., base technology and OEM joystick control) to the devices cleared in K142457. The subject device has the same intended use environment, including offroad, as the device cleared in K181908. The subject devices use the same software as the device cleared in K172384. The Magic 360 Power Wheelchair has undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no antipitch mechanism) do not affect safety and effectiveness when compared to the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in red and black, with the top half of the letters in red and the bottom half in black. Below the word "magic" is the word "Mobility" written in a cursive font. | | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Statement of Equivalence | | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | | Magic Mobility | Sunrise Medical (US) LLC | Action Manufacturing, Inc. | Sunrise Medical (US) LLC | | | | | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered Wheelchairs | Action Trackchair: Eagle 16, Eagle 18, Eagle 22, Eagle 21<br>K181908 | Quickie® Q700-UP M | | | | | | K142457 | | K172384 | | | | Indications for Use | The Magic 360 Power<br>Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. | 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. | The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and are limited to a seated position. The Action Trackchair does not require a doctor's prescription. | The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature. | Identical to primary predicate. No impact on safety or effectiveness. | | | Product Codes /<br>Regulation<br>Number | ITI /21 CFR 890.3860 | ITI / 21 CFR 890.3860 | ITI / 21 CFR 890.3860 | IPL / 21 CFR 890.3900 | Identical to primary and secondary predicate. No impact on safety and effectiveness. | | | Regulation<br>Description | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to primary and secondary predicate. No impact on safety and effectiveness. | | | Technical Specifications | | | | | | | | General | | | | | | | | Maximum User<br>Weight (lbs) | 300 | 300 | 400 | 265 | Identical to primary predicate. No impact on safety and effectiveness. | | | | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | | | | Magic Mobility | Sunrise Medical (US) LLC | Action Manufacturing,<br>Inc. | Sunrise Medical (US) LLC | Statement of<br>Equivalence | | | | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered<br>Wheelchairs | Action Trackchair: Eagle<br>16, Eagle 18, Eagle 22,<br>Eagle 21 | Quickie® Q700-UP M | | | | | | K142457 | K181908 | K172384 | | | | Storage<br>Temperature<br>(°C) | -40 to 70 | -40 to 70 | Unknown | -40 to 70 | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Location for Use | Indoors and outdoors including<br>care facilities, residences, and<br>soft/rough terrain. | Indoors and outdoors including care<br>facilities, and residences | Indoors and outdoors<br>including care facilities,<br>residences, and<br>soft/rough terrain. | Indoors and outdoors<br>including care facilities,<br>and residences | Identical to predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | | Frame Material | Steel and aluminum | Steel and aluminum | Unknown | Steel and aluminum | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Biocompatibility | Uses materials common to<br>many wheelchairs | Uses materials common to many<br>wheelchairs | Uses materials common<br>to many wheelchairs | Uses materials common<br>to many wheelchairs | Identical to predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | | Maximum Speed<br>(mph) | 6 | 6 | 3 | 6 (with an option of 8) | Identical to primary<br>predicate. No impact on<br>safety and effectiveness. | | | Base<br>Overall<br>Dimensions<br>(length by<br>width) | 26"x38.7" | 24"x34" | 42"x52.5" | 25"x36" | Substantially equivalent<br>to the predicate and<br>reference devices. No<br>impact on safety and<br>effectiveness. | | | Rolling Base<br>Weight (lbs) | 130 | 130 | Unknown | 152 | Identical to primary<br>predicate. No impact on<br>safety and effectiveness. | | | Power Source | Batteries | Batteries | Batteries | Batteries | Identical to predicate | | | | | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | | | | Magic Mobility | Sunrise Medical (US) LLC | Action Manufacturing, Inc.<br> | Sunrise Medical (US) LLC | Statement of<br>Equivalence | | | | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered<br>Wheelchairs | Action Trackchair: Eagle<br>16, Eagle 18, Eagle 22,<br>Eagle 21<br>K181908 | Quickie® Q700-UP M | | | | | | K142457 | | K172384 | and reference devices.<br>No impact on safety and<br>effectiveness. | | Battery Details | | 24V (2x12V) / 73 Ah/20h | 22 NF, sealed lead acid or gel cell | 24 V (2x12V) | 24V (2x12V) / 73 Ah/20h | Identical to secondary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | Drive Wheel<br>Diameter<br>(inches) | | 14 | 13 | Unknown | 14 | Identical to reference<br>device. No impact on<br>safety and effectiveness. | | Castor<br>Wheel<br>Size<br>(inches) | Front | 8 | 7 | Unknown | 6 | Substantially equivalent<br>to the primary predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | | Rear | 8" | 6 | Unknown | 6 | Substantially equivalent<br>to the primary predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | Anti-pitch<br>Mechanism for<br>Climbing | | None | Additional anti-pitch lock out | Unknown | Additional anti-pitch<br>lock out | Substantially equivalent<br>to the primary predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | Range (miles) | | 22.5 | Unknown | 10 | Unknown | Substantially equivalent<br>to the predicate and<br>reference devices. No<br>impact on safety and<br>effectiveness. | | | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | | | | Magic Mobility<br>Magic 360 Power Wheelchair | Sunrise Medical (US) LLC<br>Quickie® and Zippie® Powered<br>Wheelchairs<br>K142457 | Action Manufacturing, Inc.<br>Action Trackchair: Eagle 16, Eagle 18, Eagle 22,<br>Eagle 21<br>K181908 | Sunrise Medical (US) LLC<br>Quickie® Q700-UP M<br>K172384 | Statement of<br>Equivalence | | | Lift Range<br>(inches) | 0-12 | 0-12 | Unknown | 0-12 | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Tilt Range<br>(degrees) | 0-50 | 0-50 | 20 (forward and back) | 0-50 | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Recline Range<br>(degrees) | 0-170 | 0-170 | Unknown | 0-172 | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Suspension | Independent drive wheel<br>suspension with shock<br>absorbers | Standard all wheel suspension with<br>shock absorbers | Unknown | Suspension lock system | Substantially equivalent<br>to the primary predicate<br>and reference devices.<br>No impact on safety and<br>effectiveness. | | | Type of Braking<br>System | Electromagnetic, regenerative<br>brakes with a free-wheeling<br>mode | Electromagnetic | Unknown | Unknown | Identical to the primary<br>predicate. No impact on<br>safety and effectiveness. | | | User Controller | Joystick and hand control<br>buttons | Joystick and hand control buttons | Joystick | Joystick and hand<br>control buttons | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | Joystick Mount | Fixed mount, height<br>adjustable, swing-away | Fixed mount, height adjustable,<br>swing-away | Unknown | Fixed mount, height<br>adjustable, swing-away | Identical to primary<br>predicate and reference<br>devices. No impact on<br>safety and effectiveness. | | | | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | | | | Magic Mobility | Sunrise Medical (US) LLC | Action Manufacturing, Inc.<br> | Sunrise Medical (US) LLC | Statement of<br>Equivalence | | | | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered<br>Wheelchairs | Action Trackchair: Eagle<br>16, Eagle 18, Eagle 22,<br>Eagle 21<br>K181908 | Quickie® Q700-UP M | | | | | | K142457 | | K172384 | | | | Folding<br>mechanism | Yes (fold forward kit accessory) | Yes (fold down backrest) | Unknown | Unknown | Substantially equivalent<br>to the primary<br>predicate. No impact on<br>safety and effectiveness. | | | Software | | | | | | | | Software | R-Net from PGDT | VR2 from PGDT | Unknown | R-Net from PGDT | Identical to reference<br>device. No impact on<br>safety and effectiveness. | | | Seat/Armrest/Footrest | | | | | |…