(155 days)
No
The description focuses on the mechanical and electrical aspects of a power wheelchair and its accessories, with no mention of AI or ML capabilities. The performance studies listed are standard tests for wheelchair safety and functionality, not related to AI/ML performance.
Yes
The device is intended for "medical purposes to provide mobility to persons restricted to a sitting position," which indicates a therapeutic use.
No
The device is a power wheelchair, a mobility aid for individuals restricted to a sitting position, not a diagnostic tool used to identify or determine the nature of a disease or condition.
No
The device description clearly indicates it is a physical power wheelchair with battery, electric motor, wheels, and various hardware components and accessories. The performance studies also focus on physical characteristics and safety standards for a power wheelchair.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Magic 360 Power Wheelchair Function: The Magic 360 Power Wheelchair is a mobility device. Its purpose is to provide transportation and support for individuals with mobility limitations. It does not interact with or analyze biological specimens.
The provided text clearly describes a power wheelchair and its features, all related to mobility and user comfort. There is no mention of any diagnostic testing or analysis of biological samples.
N/A
Intended Use / 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.
Product codes
ITI
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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)
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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 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
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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
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.
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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 21 | ||||
| K181908 | Quickie® Q700-UP M | |||||
| K142457 | K172384 | |||||
| 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. | 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 / | ||||||
| Regulation | ||||||
| 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 | ||||||
| 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 | ||||||
| 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, | ||||
| Inc. | Sunrise Medical (US) LLC | Statement of | ||||
| Equivalence | ||||||
| Magic 360 Power Wheelchair | Quickie® and Zippie® Powered | |||||
| Wheelchairs | Action Trackchair: Eagle | |||||
| 16, Eagle 18, Eagle 22, | ||||||
| Eagle 21 | Quickie® Q700-UP M | |||||
| K142457 | K181908 | K172384 | ||||
| Storage | ||||||
| Temperature | ||||||
| (°C) | -40 to 70 | -40 to 70 | Unknown | -40 to 70 | Identical to primary | |
| predicate and reference | ||||||
| devices. No impact on | ||||||
| safety and effectiveness. | ||||||
| Location for Use | Indoors and outdoors including | |||||
| care facilities, residences, and | ||||||
| soft/rough terrain. | Indoors and outdoors including care | |||||
| facilities, and residences | Indoors and outdoors | |||||
| including care facilities, | ||||||
| residences, and | ||||||
| soft/rough terrain. | Indoors and outdoors | |||||
| including care facilities, | ||||||
| and residences | Identical to predicate | |||||
| and reference devices. | ||||||
| No impact on safety and | ||||||
| effectiveness. | ||||||
| Frame Material | Steel and aluminum | Steel and aluminum | Unknown | Steel and aluminum | Identical to primary | |
| predicate and reference | ||||||
| devices. No impact on | ||||||
| safety and effectiveness. | ||||||
| Biocompatibility | Uses materials common to | |||||
| many wheelchairs | Uses materials common to many | |||||
| wheelchairs | Uses materials common | |||||
| to many wheelchairs | Uses materials common | |||||
| to many wheelchairs | Identical to predicate | |||||
| and reference devices. | ||||||
| No impact on safety and | ||||||
| effectiveness. | ||||||
| Maximum Speed | ||||||
| (mph) | 6 | 6 | 3 | 6 (with an option of 8) | Identical to primary | |
| predicate. No impact on | ||||||
| safety and effectiveness. | ||||||
| Base | ||||||
| Overall | ||||||
| Dimensions | ||||||
| (length by | ||||||
| width) | 26"x38.7" | 24"x34" | 42"x52.5" | 25"x36" | Substantially equivalent | |
| to the predicate and | ||||||
| reference devices. No | ||||||
| impact on safety and | ||||||
| effectiveness. | ||||||
| Rolling Base | ||||||
| Weight (lbs) | 130 | 130 | Unknown | 152 | Identical to primary | |
| predicate. No impact on | ||||||
| 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. |
| Sunrise Medical (US) LLC | Statement of
Equivalence |
| | | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered
Wheelchairs | Action Trackchair: Eagle
16, Eagle 18, Eagle 22,
Eagle 21
K181908 | Quickie® Q700-UP M | |
| | | | K142457 | | K172384 | and reference devices.
No impact on safety and
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
predicate and reference
devices. No impact on
safety and effectiveness. |
| Drive Wheel
Diameter
(inches) | | 14 | 13 | Unknown | 14 | Identical to reference
device. No impact on
safety and effectiveness. |
| Castor
Wheel
Size
(inches) | Front | 8 | 7 | Unknown | 6 | Substantially equivalent
to the primary predicate
and reference devices.
No impact on safety and
effectiveness. |
| | Rear | 8" | 6 | Unknown | 6 | Substantially equivalent
to the primary predicate
and reference devices.
No impact on safety and
effectiveness. |
| Anti-pitch
Mechanism for
Climbing | | None | Additional anti-pitch lock out | Unknown | Additional anti-pitch
lock out | Substantially equivalent
to the primary predicate
and reference devices.
No impact on safety and
effectiveness. |
| Range (miles) | | 22.5 | Unknown | 10 | Unknown | Substantially equivalent
to the predicate and
reference devices. No
impact on safety and
effectiveness. |
| | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | |
| | Magic Mobility
Magic 360 Power Wheelchair | Sunrise Medical (US) LLC
Quickie® and Zippie® Powered
Wheelchairs
K142457 | Action Manufacturing, Inc.
Action Trackchair: Eagle 16, Eagle 18, Eagle 22,
Eagle 21
K181908 | Sunrise Medical (US) LLC
Quickie® Q700-UP M
K172384 | Statement of
Equivalence | |
| Lift Range
(inches) | 0-12 | 0-12 | Unknown | 0-12 | Identical to primary
predicate and reference
devices. No impact on
safety and effectiveness. | |
| Tilt Range
(degrees) | 0-50 | 0-50 | 20 (forward and back) | 0-50 | Identical to primary
predicate and reference
devices. No impact on
safety and effectiveness. | |
| Recline Range
(degrees) | 0-170 | 0-170 | Unknown | 0-172 | Identical to primary
predicate and reference
devices. No impact on
safety and effectiveness. | |
| Suspension | Independent drive wheel
suspension with shock
absorbers | Standard all wheel suspension with
shock absorbers | Unknown | Suspension lock system | Substantially equivalent
to the primary predicate
and reference devices.
No impact on safety and
effectiveness. | |
| Type of Braking
System | Electromagnetic, regenerative
brakes with a free-wheeling
mode | Electromagnetic | 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 | Joystick and hand
control buttons | Identical to primary
predicate and reference
devices. No impact on
safety and effectiveness. | |
| Joystick Mount | Fixed mount, height
adjustable, swing-away | Fixed mount, height adjustable,
swing-away | Unknown | Fixed mount, height
adjustable, swing-away | Identical to primary
predicate and reference
devices. 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 of
Equivalence | |
| | Magic 360 Power Wheelchair | Quickie® and Zippie® Powered
Wheelchairs | Action Trackchair: Eagle
16, Eagle 18, Eagle 22,
Eagle 21
K181908 | Quickie® Q700-UP M | | |
| | | K142457 | | K172384 | | |
| Folding
mechanism | Yes (fold forward kit accessory) | Yes (fold down backrest) | Unknown | Unknown | Substantially equivalent
to the primary
predicate. No impact on
safety and effectiveness. | |
| Software | | | | | | |
| Software | R-Net from PGDT | VR2 from PGDT | Unknown | R-Net from PGDT | Identical to reference
device. No impact on
safety and effectiveness. | |
| Seat/Armrest/Footrest | | | | | | |
| Seat Height
(minimum,
inches) | 17.1 | 16.2 | 23 | 16.2 | Substantially equivalent
to the predicate and
reference devices. No
impact on safety and
effectiveness. | |
| Seat Width
(inches) | 12-22 | 12-24 | Unknown | 16-22 | Substantially equivalent
to the primary predicate
and reference devices.
No impact on safety and
effectiveness. | |
| Armrest | Height adjustable, removable,
flip up option | Height adjustable and flip up option | Unknown | Unknown | Identical to the primary
predicate. No impact on
safety and effectiveness. | |
| Footrest | 1 or 2 pieces, fixed or flip up,
angle and height adjustable
rigid footplates | Swing away footrests with heel
loops | Height adjustable | Unknown | Substantially equivalent
to the predicate devices.
No impact on safety and
effectiveness. | |
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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".
9
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.
10
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.
11
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.