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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Magic 360 Power Wheelchair. This document is a regulatory submission to the FDA for medical device clearance, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device meets acceptance criteria is not directly applicable in the AI/ML context.

However, I can extract the closest analogous information from the document as it pertains to a traditional medical device (power wheelchair).

Here's an interpretation based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria with quantitative performance metrics for the Magic 360 Power Wheelchair in the way one would for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by adherence to recognized ISO standards for wheelchairs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is inferred from the successful completion of these tests.

The comparison table provided in the document (pages 6-7) highlights the characteristics of the Magic 360 Power Wheelchair against predicate devices. The "Statement of Equivalence" column implicitly indicates that the device's performance characteristics are either identical or substantially equivalent to the predicate devices, thus meeting regulatory expectations.

Category	Acceptance Criteria (Implied)	Reported Device Performance (Implied from "Statement of Equivalence")
Indications for Use	Must be identical or substantially similar to predicate device(s) without raising new questions of safety or effectiveness.	"Identical to primary predicate. No impact on safety or effectiveness."
Product Codes / Regulation No.	Must align with predicate device(s).	"Identical to primary and secondary predicate. No impact on safety and effectiveness."
Regulation Description	Must align with predicate device(s).	"Identical to primary and secondary predicate. No impact on safety and effectiveness."
Maximum User Weight (lbs)	Must be within acceptable limits compared to predicate(s) and demonstrate safety and effectiveness for stated weight.	"Identical to primary predicate. No impact on safety and effectiveness." (300 lbs)
Storage Temperature (°C)	Must meet relevant standards for safe storage.	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (-40 to 70 °C)
Location for Use	Must be comparable to predicate(s) or justified through testing for safety and effectiveness.	"Identical to predicate and reference devices. No impact on safety and effectiveness." (Indoors and outdoors including care facilities, residences, and soft/rough terrain)
Frame Material	Must be biocompatible and structurally sound.	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Steel and aluminum)
Biocompatibility	Materials must be common to many wheelchairs and pass relevant ISO standards.	"Identical to predicate and reference devices. No impact on safety and effectiveness." (Uses materials common to many wheelchairs and passed ISO 10993 tests)
Maximum Speed (mph)	Must be comparable to predicate(s) and safe.	"Identical to primary predicate. No impact on safety and effectiveness." (6 mph)
Base Overall Dimensions	Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness.	"Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (26"x38.7")
Rolling Base Weight (lbs)	Must be comparable to predicate(s) and demonstrate safety and effectiveness.	"Identical to primary predicate. No impact on safety and effectiveness." (130 lbs)
Power Source	Must be safe and effective.	"Identical to predicate and reference devices. No impact on safety and effectiveness." (Batteries)
Battery Details	Must be safe and effective, and comparable to predicate(s).	"Identical to secondary predicate and reference devices. No impact on safety and effectiveness." (24V (2x12V) / 73 Ah/20h, similar to K181908 and K172384)
Drive Wheel Diameter (inches)	Must be comparable to predicate(s) and not negatively impact safety or effectiveness.	"Identical to reference device. No impact on safety and effectiveness." (14 inches)
Castor Wheel Size (inches)	Must be comparable to predicate(s) and not negatively impact safety or effectiveness.	"Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (Front 8", Rear 8")
Anti-pitch Mechanism	Functionality should be comparable to predicate(s) or justified for safety and effectiveness without one. The subject device has "None" but is deemed substantially equivalent based on testing for differences in technological characteristics.	"Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (None, despite predicates having additional anti-pitch lock out; testing justifies this difference)
Range (miles)	Must be comparable to predicate(s).	"Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (22.5 miles)
Lift Range (inches)	Must be comparable to predicate(s).	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-12 inches)
Tilt Range (degrees)	Must be comparable to predicate(s).	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-50 degrees)
Recline Range (degrees)	Must be comparable to predicate(s).	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-170 degrees)
Suspension	Must provide equivalent safety and effectiveness to predicate(s).	"Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (Independent drive wheel suspension with shock absorbers)
Type of Braking System	Must be safe and effective.	"Identical to the primary predicate. No impact on safety and effectiveness." (Electromagnetic, regenerative brakes with a free-wheeling mode)
User Controller	Must be safe and effective and provide appropriate control.	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Joystick and hand control buttons)
Joystick Mount	Must be safe and provide appropriate adjustability.	"Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Fixed mount, height adjustable, swing-away)
Folding mechanism	Must be safe and effective, and comparable to predicate(s).	"Substantially equivalent to the primary predicate. No impact on safety and effectiveness." (Yes, with fold forward kit accessory)
Software	Must be safe and effective, and comparable to predicate(s).	"Identical to reference device. No impact on safety and effectiveness." (R-Net from PGDT)
Seat Height (minimum, inches)	Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness.	"Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (17.1 inches)
Seat Width (inches)	Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness.	"Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (12-22 inches)
Armrest	Must provide equivalent safety and effectiveness to predicate(s).	"Identical to the primary predicate. No impact on safety and effectiveness." (Height adjustable, removable, flip up option)
Footrest	Must provide equivalent safety and effectiveness to predicate(s).	"Substantially equivalent to the predicate devices. No impact on safety and effectiveness." (1 or 2 pieces, fixed or flip up, angle and height adjustable rigid footplates)
ISO Standards Compliance	Must meet all relevant ISO standards for wheelchairs.	"The results of these tests indicate that the Magic 360 Power Wheelchair are substantially equivalent to the predicate devices." (Passed 20+ ISO tests and biocompatibility tests as listed in "SUMMARY OF NON-CLINICAL TESTING")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided because this is a submission for a physical medical device (power wheelchair) and not an AI/ML algorithm. The "test set" in this context refers to physical units of the wheelchair undergoing standardized engineering and performance tests, not a dataset for an algorithm. There is no mention of "data provenance" in the sense of patient data. The manufacturer is based in Australia ("3 International Court, Scoresby, VIC, 3179 Australia").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. "Ground truth" in this context would implicitly be the established engineering specifications and performance requirements defined by ISO standards and regulatory guidelines, confirmed through physical testing by qualified engineers or technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept relates to human review of data, which is not described for the performance testing of this physical device. The testing described (e.g., Static stability, Dynamic stability, EMC testing) are objective engineering measurements against defined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device's performance is established by international consensus standards (ISO standards) for wheelchairs regarding functionality, safety, and durability, as well as the performance characteristics of legally marketed predicate devices. The testing verifies that the device performs according to these objective standards and is comparable to equivalent devices already on the market.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." The device is designed, manufactured, and tested to engineering specifications.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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

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Indications for Use

510(k) Number (if known) K203083

Device Name Magic 360 Power Wheelchair

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the "m" and "c" in red and the "a", "g", and "i" in black. Below the word "magic" is the word "Mobility" written in a cursive font. 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 /Sunrise Medical (US) LLC	Primary Predicate
K181908	Action Trackchair: Eagle 16, Eagle 18, Eagle 20,Eagle 22, Eagle 24 / Action Manufacturing Inc.	Secondary Predicate
K172384	Quickie® Q700-UP M / Sunrise Medical (US) LLC	Reference Device

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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 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

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

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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

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.

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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 21K181908	Quickie® Q700-UP M
		K142457		K172384
Indications for Use	The Magic 360 PowerWheelchair 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 /RegulationNumber	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.
RegulationDescription	Powered Wheelchair	Powered Wheelchair	Powered Wheelchair	Standup Wheelchair	Identical to primary and secondary predicate. No impact on safety and effectiveness.
Technical Specifications
General
Maximum UserWeight (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,Inc.	Sunrise Medical (US) LLC	Statement ofEquivalence
	Magic 360 Power Wheelchair	Quickie® and Zippie® PoweredWheelchairs	Action Trackchair: Eagle16, Eagle 18, Eagle 22,Eagle 21	Quickie® Q700-UP M
		K142457	K181908	K172384
StorageTemperature(°C)	-40 to 70	-40 to 70	Unknown	-40 to 70	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Location for Use	Indoors and outdoors includingcare facilities, residences, andsoft/rough terrain.	Indoors and outdoors including carefacilities, and residences	Indoors and outdoorsincluding care facilities,residences, andsoft/rough terrain.	Indoors and outdoorsincluding care facilities,and residences	Identical to predicateand reference devices.No impact on safety andeffectiveness.
Frame Material	Steel and aluminum	Steel and aluminum	Unknown	Steel and aluminum	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Biocompatibility	Uses materials common tomany wheelchairs	Uses materials common to manywheelchairs	Uses materials commonto many wheelchairs	Uses materials commonto many wheelchairs	Identical to predicateand reference devices.No impact on safety andeffectiveness.
Maximum Speed(mph)	6	6	3	6 (with an option of 8)	Identical to primarypredicate. No impact onsafety and effectiveness.
BaseOverallDimensions(length bywidth)	26"x38.7"	24"x34"	42"x52.5"	25"x36"	Substantially equivalentto the predicate andreference devices. Noimpact on safety andeffectiveness.
Rolling BaseWeight (lbs)	130	130	Unknown	152	Identical to primarypredicate. No impact onsafety 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.	Sunrise Medical (US) LLC	Statement ofEquivalence
		Magic 360 Power Wheelchair	Quickie® and Zippie® PoweredWheelchairs	Action Trackchair: Eagle16, Eagle 18, Eagle 22,Eagle 21K181908	Quickie® Q700-UP M
			K142457		K172384	and reference devices.No impact on safety andeffectiveness.
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 secondarypredicate and referencedevices. No impact onsafety and effectiveness.
Drive WheelDiameter(inches)		14	13	Unknown	14	Identical to referencedevice. No impact onsafety and effectiveness.
CastorWheelSize(inches)	Front	8	7	Unknown	6	Substantially equivalentto the primary predicateand reference devices.No impact on safety andeffectiveness.
	Rear	8"	6	Unknown	6	Substantially equivalentto the primary predicateand reference devices.No impact on safety andeffectiveness.
Anti-pitchMechanism forClimbing		None	Additional anti-pitch lock out	Unknown	Additional anti-pitchlock out	Substantially equivalentto the primary predicateand reference devices.No impact on safety andeffectiveness.
Range (miles)		22.5	Unknown	10	Unknown	Substantially equivalentto the predicate andreference devices. Noimpact on safety andeffectiveness.
	Subject Device	Primary Predicate Device	Predicate Device	Reference Device
	Magic MobilityMagic 360 Power Wheelchair	Sunrise Medical (US) LLCQuickie® and Zippie® PoweredWheelchairsK142457	Action Manufacturing, Inc.Action Trackchair: Eagle 16, Eagle 18, Eagle 22,Eagle 21K181908	Sunrise Medical (US) LLCQuickie® Q700-UP MK172384	Statement ofEquivalence
Lift Range(inches)	0-12	0-12	Unknown	0-12	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Tilt Range(degrees)	0-50	0-50	20 (forward and back)	0-50	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Recline Range(degrees)	0-170	0-170	Unknown	0-172	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Suspension	Independent drive wheelsuspension with shockabsorbers	Standard all wheel suspension withshock absorbers	Unknown	Suspension lock system	Substantially equivalentto the primary predicateand reference devices.No impact on safety andeffectiveness.
Type of BrakingSystem	Electromagnetic, regenerativebrakes with a free-wheelingmode	Electromagnetic	Unknown	Unknown	Identical to the primarypredicate. No impact onsafety and effectiveness.
User Controller	Joystick and hand controlbuttons	Joystick and hand control buttons	Joystick	Joystick and handcontrol buttons	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
Joystick Mount	Fixed mount, heightadjustable, swing-away	Fixed mount, height adjustable,swing-away	Unknown	Fixed mount, heightadjustable, swing-away	Identical to primarypredicate and referencedevices. No impact onsafety and effectiveness.
	Subject Device	Primary Predicate Device	Predicate Device	Reference Device
	Magic Mobility	Sunrise Medical (US) LLC	Action Manufacturing, Inc.	Sunrise Medical (US) LLC	Statement ofEquivalence
	Magic 360 Power Wheelchair	Quickie® and Zippie® PoweredWheelchairs	Action Trackchair: Eagle16, Eagle 18, Eagle 22,Eagle 21K181908	Quickie® Q700-UP M
		K142457		K172384
Foldingmechanism	Yes (fold forward kit accessory)	Yes (fold down backrest)	Unknown	Unknown	Substantially equivalentto the primarypredicate. No impact onsafety and effectiveness.
Software
Software	R-Net from PGDT	VR2 from PGDT	Unknown	R-Net from PGDT	Identical to referencedevice. No impact onsafety and effectiveness.
Seat/Armrest/Footrest
Seat Height(minimum,inches)	17.1	16.2	23	16.2	Substantially equivalentto the predicate andreference devices. Noimpact on safety andeffectiveness.
Seat Width(inches)	12-22	12-24	Unknown	16-22	Substantially equivalentto the primary predicateand reference devices.No impact on safety andeffectiveness.
Armrest	Height adjustable, removable,flip up option	Height adjustable and flip up option	Unknown	Unknown	Identical to the primarypredicate. No impact onsafety and effectiveness.
Footrest	1 or 2 pieces, fixed or flip up,angle and height adjustablerigid footplates	Swing away footrests with heelloops	Height adjustable	Unknown	Substantially equivalentto the predicate devices.No impact on safety andeffectiveness.

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Image /page/7/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is in red and black, with the top half of the letters in red and the bottom half in black. The word "Mobility" is in black cursive font and is located below the word "magic". The logo is simple and modern.

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Image /page/8/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is in red, with the "m" and "c" in a larger font size than the "a", "g", and "i". The word "Mobility" is in black and in a cursive font, and it is located below the word "magic".

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Image /page/9/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.

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Image /page/10/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.

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Image /page/11/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is in red and black, with the top half of the letters in red and the bottom half in black. The word "Mobility" is in black and is written in cursive below the word "magic."

SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards:

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)
Determination of coefficient of friction of test surfaces (per ISO 7176-13)
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)
EMC testing (per ISO 7176-21)
Batteries and chargers per (per ISO 7176-25)
. Vocabulary (per ISO 7176-26)
Changing occupant posture (per ISO 7176-30)
Evaluation and testing within a risk management process (per ISO 10993-1)
In vitro cytotoxicity (per ISO 10993-5)
Irritation and skin sensitization (per ISO 10993-10)

The results of these tests indicate that the Magic 360 Power Wheelchair are substantially equivalent to the predicate devices.

CONCLUSION

Based on the testing performed (including wheelchair dynamic testing and flammability) it can be concluded that the subject device does 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 Magic 360 Power Wheelchair is assessed to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).