Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard power wheelchair and the testing performed is related to mechanical and electrical safety standards, not AI/ML performance. There is no mention of AI, ML, or related concepts.

Therapeutic

No.
The device provides mobility assistance rather than directly treating a medical condition or restoring a bodily function.

Diagnostic

No

Explanation: The device is a power wheelchair intended to provide mobility, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "battery powered, electric motor driven device" with "wheels," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health, or screen for conditions.
The description of the Frontier Series Power Wheelchairs clearly states their purpose is to provide mobility to individuals restricted to a sitting position. They are mechanical devices designed for transportation and assistance with movement.
The "Intended Use / Indications for Use" and "Device Description" sections focus on the physical function and operation of the wheelchair. There is no mention of analyzing biological samples or performing diagnostic tests.
The performance studies listed are related to the physical and electrical safety and functionality of the wheelchair, not diagnostic accuracy or biological analysis.

In summary, the Frontier Series Power Wheelchairs are mobility devices, not diagnostic tools that analyze samples from the human body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

ITI

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 ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults and children

Intended User / Care Setting

Indoor and outdoor environments including care facilities and private residences.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed to demonstrate substantial equivalence based on current industry and FDA recognized standards.

Performance tests conducted:

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 tests:

EMC testing (per ISO 7176-21)
Batteries and chargers per (per ISO 7176-25)

Biocompatibility tests:

Evaluation and testing within a risk management process (per ISO 10993-1)
In vitro cytotoxicity (per ISO 10993-5)

Software test:

Software life cycle process (per IEC 62304)

Key results: The results of these tests indicate that the Frontier Series Power Wheelchairs are substantially equivalent to the predicate devices. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030783, K142457

Reference Device(s)

K172384

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

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

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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)

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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
Device
K142457	Quickie® and Zippie® Powered Wheelchairs /
Sunrise Medical (US) LLC	Secondary Predicate
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
Wheelchairs	Frontier Power Wheelchair	Quickie® and Zippie® Powered
Wheelchairs	Quickie® Q700-UP M	Substantially equivalent to
predicate devices.
	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.	K030783
The intended use of the
Frontier Power wheelchair
is to provide mobility to
persons limited to a sitting
position, who have the
capability of operating a
power wheelchair.	K142457
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.	K172384
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.
Product Codes /
Regulation
Number	ITI/21 CFR 890.3860	ITI/21 CFR 890.3860	ITI/21 CFR 890.3860	IPL/21 CFR
890.3900	Identical to the primary predicate.
No impact on safety and
effectiveness.
Regulation
Description	Powered Wheelchair	Powered Wheelchair	Powered Wheelchair	Standup Wheelchair	Identical to the primary predicate.
No impact on safety and
effectiveness.
Technical Specifications
General
Maximum User
Weight (lbs)	Frontier V4 FWD: 400
Frontier V4 RWD: 400
Frontier V6: 400
Frontier V6 C73:400	400	300	265	Identical to the primary predicate.
No impact on safety and
effectiveness.
Storage
Temperature
(°C)	-40 to 70	-40 to 70	-40 to 70	-40 to 70	Identical to the primary predicate.
No impact on safety and
effectiveness.
Location for
Use	Indoors and outdoors
including care facilities,
and residences	Indoors and outdoors
including care facilities, and
residences	Indoors and outdoors including
care facilities, and residences	Indoors and
outdoors including
care facilities, and
residences	Identical to the primary predicate.
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
Frontier Series Power
Wheelchairs	Innovation in Motion
Frontier Power Wheelchair	Sunrise Medical (US) LLC
Quickie® and Zippie® Powered
Wheelchairs	Sunrise Medical (US)
LLC
Quickie® Q700-UP M
	K030783	K142457	K172384
Biocompatibility	Uses materials common to
many wheelchairs	Uses materials common to many
wheelchairs	Uses materials
common to many
wheelchairs	No impact on safety and
effectiveness.
Identical to the primary predicate.
No impact on safety and
effectiveness.
Base
Overall
Dimensions
(length by
width; inches)	43.34 x 28	24"x34"	25"x36"	Substantially equivalent to the
predicate and reference devices.
No impact on safety and
effectiveness.
Frontier V4 FWD AT tires:
39.2 x28
Frontier V4 FWD Hybrid
tires: 39.2 x 26.3
Frontier V4 RWD AT tires:
36.6 x 28
Frontier V4 RWD Hybrid
tires: 36.6 x 26.3
Frontier V6 AT tires:
42 x 28
Frontier V6 Hybrid tires:
42 x 27.5
Frontier V6 C73:
39.5 x 25.5
Rolling Base
Weight (lbs)	260 (with batteries)	130	152	Substantially equivalent to the
predicate device. No impact on
safety and effectiveness.
Power Source	Batteries	Batteries	Batteries	Identical to the primary predicate.
No impact on safety and
effectiveness.

7

8

| Subject Devices
Magic Mobility | Predicate Device
Innovation in Motion
Frontier Series Power
Wheelchairs | Predicate Device
Sunrise Medical (US) LLC
Quickie® and Zippie® Powered
Wheelchairs | Reference Device
Sunrise Medical (US) LLC | Statement of Equivalence |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------|
| | Frontier Power Wheelchair | | Quickie® Q700-UP M | |
| Battery Details | Two (2) 73 Ahr | K142457
22 NF, sealed lead acid or gel cell | K172384
24V (2x12V)/73
Ah/20h | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Castor Wheel
Size (inches) | 8.25 x 2.5 | Unknown | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Range (miles) | 15-20 | Unknown | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Anti-pitch
Mechanism for
Climbing | None | Additional anti-pitch lock out | Additional anti-pitch
lock out | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Lift Range
(inches) | 0-12 | 0-12 | 0-12 | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Tilt Range
(degrees) | 0-50 | 0-50 | 0-50 | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Recline Range
(degrees) | 0-170 | 0-170 | 0-172 | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Suspension | Independent drive wheel
suspension with shock
absorber on pivoting
swing arm and
articulated castors to
ensure all wheels
maintain adhesion at all
surface angles | Independent drive wheel
suspension with shock
absorber on pivoting swing
arm and articulated castors
to ensure all wheels
maintain adhesion at all
surface angles | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Maximum
speed (mm) | 6 | 6 | 6 (with an option of
8) | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Subject Devices | Predicate Device
Innovation in Motion | Predicate Device
Sunrise Medical (US) LLC | Reference Device
Sunrise Medical (US)
LLC | Statement of Equivalence |
| Magic Mobility
Frontier Series Power
Wheelchairs | Frontier Power Wheelchair | Quickie® and Zippie® Powered
Wheelchairs | Quickie® Q700-UP M | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| | K030783 | K142457 | K172384 | |
| Minimum
Braking
Distance at
Maximum
Speed (meters) | 1.8 | Unknown | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| User Controller | Joystick and hand control
buttons | Joystick and hand control buttons | Joystick and hand
control buttons | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Joystick Mount | Joystick and hand control
buttons | Fixed mount, height adjustable,
swing-away | Fixed mount, height
adjustable, swing-
away | Identical to the predicate and
reference devices. No impact on
safety and effectiveness. |
| Software | R-Net from PGDT | VR2 from PGDT | R-Net from PGDT | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Seat/Armrest/Footrest | | | | |
| Seat Height
(minimum,
inches) | 17.1 | 16.2 | 16.2" | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Seat Width
(inches) | 16-24 | 12-24 | 16-22 | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Armrest | Height adjustable,
Removable, flip up option | Unknown | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |
| Footrest | Rigid footplate, flip up
nylon | Unknown | Unknown | Identical to the primary predicate.
No impact on safety and
effectiveness. |

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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.