(88 days)
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on basic power wheelchair functionality and standard testing.
No
A therapeutic device is used for treating or curing a disease or condition. This device provides mobility assistance, which is a supportive function rather than a direct therapeutic treatment.
No
The device description indicates that the power wheelchair's purpose is to provide mobility to persons restricted to a sitting position. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states it is a "battery-operated device with wheels" and an "electric motor driven device," indicating it is a physical hardware product, not software only. The performance studies also include extensive bench testing related to the physical aspects of a wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals restricted to a sitting position. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a battery-operated power wheelchair designed for mobility. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting diseases, conditions, or infections.
- Providing information for diagnosis, monitoring, or prognosis.
- Using reagents or assays.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The XT2 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. The XT4 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 XT Series Power Wheelchair has two configurations: XT2 and XT4. They are 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 who are restricted or limited to a sitting position.
The XT 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 XT Series Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
The XT 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
- 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
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. The results of these tests indicate that the XT Series Power Wheelchair is substantially equivalent to the predicate device.
BENCH TESTING
ISO 7176-1 Static stability
ISO 7176-2 Dynamic stability
ISO 7176-3 Effectiveness of brakes
ISO 7176-4 Energy consumption
ISO 7176-5 Dimensions, mass, and maneuvering space
ISO 7176-6 Maximum speed, acceleration, and deceleration
ISO 7176-7 Measurement of seat and wheel dimensions
ISO 7176-8 Static, impact, and fatigue
ISO 7176-9 Climatic test
ISO 7176-10 Obstacle climbing
ISO 7176-11 Test dummies
ISO 7176-14 Power and control systems for power wheelchairs
ISO 7176-15 Documentation and labeling
ISO 7176-16 Resistance to ignition
ISO 7176-19 Dynamic Test
ISO 7176-26 Vocabulary
ISO 7176-30 Wheelchairs for changing occupant posture
EMC AND ELECTRICAL SAFETY
ISO 7176-21 EMC testing
ISO 7176-25 Batteries and chargers
BIOCOMPATIBILITY
ISO 10993-1 Evaluation and testing within a risk management process
The materials used in the subject device are identical composition, formulation processing, and geometry as the materials found in the Extreme X8 Power Wheelchair by Magic Mobility LLC (K211574) and the Quickie Q700-UP M by Sunrise Medical (US) LLC (K172384) device. Furthermore, the T Series Power Wheelchair has the same type and duration of patient contact as the predicate and reference devices. Therefore, based on previous use, the subject device is 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".
SOFTWARE
IEC 62304 Software life cycle process
The results of these tests indicate that the XT Series Power Wheelchair is 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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2024
Magic Mobility % Pierre Bounaud Principal Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K233877
Trade/Device Name: XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 26, 2023 Received: December 7, 2023
Dear Pierre Bounaud:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD
Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233877
Device Name
XT Series Power Wheelchair (XT2); XT Series Power Wheelchair (XT4)
Indications for Use (Describe)
The XT2 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. The XT4 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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510(k) Summary K233877
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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 first half of the word in red and the second half in black. Below the word "magic" is the word "Mobility" written in a cursive font. The logo is simple and modern, and it conveys a sense of movement and innovation.
K233877 510(k) SUMMARY
DATE PREPARED
November 26, 2023
MANUFACTURER AND 510(k) OWNER
Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Terence Walsh, Quality and Regulatory Affairs Manager
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: +1 (412) 816-8139 Email: pbounaud@rqmplus.com; akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | XT Series Power Wheelchair (XT2 and XT4 models) |
|---|---|
| Common Name: | Powered wheelchair |
| Regulation Number: | 21 CFR 890.3860 |
| Class: | II |
| Product Code: | ITI |
| Premarket Review: | OHT5/Neuromodulation and Physical Medicine Devices |
| (DHT5B) | |
| Review Panel: | Physical Medicine |
PREDICATE DEVICE IDENTIFICATION
The XT Series Power Wheelchair is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate | Reference
Device |
|---------------|-----------------------------------------------|----------------------|---------------------|
| K211574 | Extreme X8 / Magic Mobility | ✓ | |
| K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | | ✓ |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The XT Series Power Wheelchair has two configurations: XT2 and XT4. They are 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 who are restricted or limited to a sitting position.
The XT Series Power Wheelchairs are battery powered, electric motor driven devices that can be
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Image /page/6/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 in "Mobility" are black.
used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). The XT Series Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
The XT 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
- 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 safely. The XT Series Power Wheelchairs are intended to be selfpropelled on a range of surfaces and can be used on both indoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
INDICATIONS FOR USE
The XT2 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.
The XT4 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 XT Series Power Wheelchair is substantially equivalent to the predicate device 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 K211574. The subject device has the same intended use and similar technological characteristics (i.e.. base technology and OEM jovstick control) to the devices cleared in K211574 and K172384. The subject device has the same intended use environment. including off road capabilities, as the device cleared in K211574. The subject device uses the same software as the device cleared in K211574 and K172384. The Magic XT Series Power Wheelchairs have undergone testing to ensure that any differences in technological characteristics (i.e., battery size, frame design) do not affect safety and effectiveness when compared to the predicate devices.
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Image /page/7/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. Below the word "magic" is the word "Mobility" in a cursive font. The logo is simple and modern.
| Subject Device | Predicate Device | Reference Device | Statement of Equivalence | |
|---|---|---|---|---|
| Magic Mobility | ||||
| XT Series Power Wheelchair | ||||
| K233877 | Magic Mobility | |||
| Extreme X8 Power Wheelchair | ||||
| K211574 | Sunrise Medical (US) LLC | |||
| Quickie® Q700-UP M | ||||
| K172384 | ||||
| Indications for | ||||
| Use | The XT2 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. | ||||
| The XT4 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. | The Extreme X8 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. | 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 predicate device. No | |||
| impact on safety or effectiveness. | ||||
| Product Code / | ||||
| Regulation | ||||
| Number | ITI / 21 CFR 890.3860 | ITI / 21 CFR 890.3860 | IPL / 21 CFR 890.3900 | Identical to predicate device. No |
| impact on safety and effectiveness. | ||||
| Regulation | ||||
| Description | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to predicate device. No |
| impact on safety and effectiveness. | ||||
| Maximum User | ||||
| Weight (lbs) | XT2: 300 | |||
| XT4: 400 | 400 | 265 | Similar to predicate device. No | |
| impact on safety and effectiveness. | ||||
| Storage | ||||
| Temperature | ||||
| (°C) | -40 to 70°C | -40 to 70°C | -40 to 70°C | Identical to 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, 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 | Steel | Steel and aluminum | Identical to 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 | Identical to predicate and reference | |||
| devices. No impact on safety and | ||||
| effectiveness. | ||||
| Ground | ||||
| Clearance | 5" | 4" | Unknown | Similar to predicate device. No |
| impact on safety and effectiveness. | ||||
| Subject Device | Predicate Device | Reference Device | ||
| Magic Mobility | ||||
| XT Series Power Wheelchair | ||||
| K233877 | Magic Mobility | |||
| Extreme X8 Power Wheelchair | ||||
| K211574 | Sunrise Medical (US) LLC | |||
| Quickie® Q700-UP M | ||||
| K172384 | Statement of Equivalence | |||
| Overall Dimensions | ||||
| (length by width; inches) | XT2: 43.5" x 27" | |||
| XT4: 39.5"x 27.5" | 45.25" x 27" | 25" x 26" | Similar to predicate device. No impact on safety and effectiveness. | |
| Rolling Base Weight (lbs) | XT2: 167 | |||
| XT4: 183 | 145 | 152 | Similar to predicate device. No impact on safety and effectiveness. | |
| Power Source | Batteries | Batteries | Batteries | Identical to predicate and reference devices. No impact on safety and effectiveness. |
| Battery Details | 2- Group 31 12-volt AGM or Gel | |||
| 20h capacity in 95-115 AMP/hour range. | 2- 73 AMP/hour AGM Group 24 12-volt | |||
| Weight 55 lbs | 24V (2x12V) / 73 Ah/20h | Similar to predicate device. No impact on safety and effectiveness. | ||
| Battery Charger Input Voltage | ||||
| (volts) | 110 | 110 | Unknown | Identical to predicate device. No impact on safety and effectiveness. |
| Motors | XT2: 2 motors | |||
| XT4: 4 motors | ||||
| 24V, 4 pole direct drive gear in line motors/gearbox. Freewheeling lever/motor lock releases & engages motor brakes | 4-24V, 4 pole direct drive gear in line motors/gearbox. Freewheeling lever/motor lock releases & engages rear motor brakes | Unknown | Similar to predicate device. No impact on safety and effectiveness. | |
| Wheel Size | ||||
| (inches) | 4" x 14" | 4" x 14" | Unknown | Identical to predicate device. No impact on safety and effectiveness. |
| Turning Radius | ||||
| (inches) | XT2: 69" | |||
| XT4: 55.5" | 52" | Unknown | Similar to predicate device. No impact on safety and effectiveness. | |
| Range (miles) | XT2: 33 | |||
| XT4: 24 | 15.5 | Unknown | Similar to predicate device. No impact on safety and effectiveness. | |
| Maximum Speed (mph) | 6.2 | 6.2 | 6 (with an option of 8) | Identical to predicate device. No impact on safety and effectiveness. |
| Anti-pitch Mechanism for Climbing | None | None | Additional anti-pitch lock out | Identical to predicate device. No impact on safety and effectiveness. |
| Lift Range | ||||
| (inches) | 0-12" | 0-12" | 0-12" | Identical to predicate device. No impact on safety and effectiveness. |
| Tilt Range | ||||
| (degrees) | 0-50 | 0-50 | 0-50 | Identical to predicate device. No impact on safety and effectiveness. |
| Subject Device | Predicate Device | Reference Device | ||
| Magic Mobility | ||||
| XT Series Power Wheelchair | ||||
| K233877 | Magic Mobility | |||
| Extreme X8 Power Wheelchair | ||||
| K211574 | Sunrise Medical (US) LLC | |||
| Quickie® Q700-UP M | ||||
| K172384 | Statement of Equivalence | |||
| Recline Range | ||||
| (degrees) | 0-170 | 0-170 | 0-172 | Identical to predicate device. No |
| impact on safety and effectiveness. | ||||
| Suspension | Front and Rear | None | Unknown | Similar to predicate device. No |
| impact on safety and effectiveness. | ||||
| Braking System | Electromagnetic, regenerative brakes with | |||
| a free-wheeling mode | Electromagnetic, regenerative brakes | |||
| with a free-wheeling mode | Unknown | Identical to predicate device. No | ||
| impact on safety and effectiveness. | ||||
| Minimum | ||||
| Braking | ||||
| Distance at | ||||
| Maximum | ||||
| Speed (meters) | 1.7 | 1.7 | Unknown | Identical to predicate device. 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 predicate device. No |
| impact on safety and effectiveness. | ||||
| Joystick Mount | Fixed mount, height adjustable, swing- | |||
| away | Fixed mount, height adjustable, swing- | |||
| away | Fixed mount, height adjustable, swing- | |||
| away | Identical to predicate device. No | |||
| impact on safety and effectiveness. | ||||
| Software | R-Net from PGDT | R-Net from PGDT | R-Net from PGDT | Identical to predicate device. No |
| impact on safety and effectiveness. | ||||
| Seat Height | ||||
| (minimum, | ||||
| inches) | 19" | 19" | 16.2" | Identical to predicate device. No |
| impact on safety and effectiveness. | ||||
| Seat Width | ||||
| (inches) | 12"-24" | 16"-24" | 16"-22" | Similar to predicate device. No |
| impact on safety and effectiveness. | ||||
| Armrest | Height adjustable, removable, flip up | |||
| option | Height adjustable, removable, flip up | |||
| option | Unknown | Identical to predicate device. No | ||
| impact on safety and effectiveness. | ||||
| Footrest | 1 or 2 pieces, fixed or flip up, angle and | |||
| height adjustable rigid footplates, and | ||||
| others | 1 or 2 pieces, fixed or flip up, angle and | |||
| height adjustable rigid footplates, and | ||||
| others | Unknown | Identical to predicate device. No | ||
| impact on safety and effectiveness. |
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Image /page/8/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the first two letters in red and the last three letters in black. The word "Mobility" is written in a cursive font below the word "magic". The logo is simple and modern, and it is likely used to represent a company that sells mobility products or services.
9
Image /page/9/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. Below the word "magic" is the word "Mobility" in a cursive font. The logo is simple and modern.
10
Image /page/10/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the first half in red and the second half in black. Below the word "magic" is the word "Mobility" written in a cursive font, also in black. The TM symbol is in the bottom right corner of the word "Mobility".
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 XT Series Power Wheelchair is substantially equivalent to the predicate device.
| BENCH TESTING | |
|---|---|
| ISO 7176-1 | Static stability |
| ISO 7176-2 | Dynamic stability |
| ISO 7176-3 | Effectiveness of brakes |
| ISO 7176-4 | Energy consumption |
| ISO 7176-5 | Dimensions, mass, and maneuvering space |
| ISO 7176-6 | Maximum speed, acceleration, and deceleration |
| ISO 7176-7 | Measurement of seat and wheel dimensions |
| ISO 7176-8 | Static, impact, and fatigue |
| ISO 7176-9 | Climatic test |
| ISO 7176-10 | Obstacle climbing |
| ISO 7176-11 | Test dummies |
| ISO 7176-14 | Power and control systems for power wheelchairs |
| ISO 7176-15 | Documentation and labeling |
| ISO 7176-16 | Resistance to ignition |
| ISO 7176-19 | Dynamic Test |
| ISO 7176-26 | Vocabulary |
| ISO 7176-30 | Wheelchairs for changing occupant posture |
| EMC AND ELECTRICAL SAFETY | |
| ISO 7176-21 | EMC testing |
| ISO 7176-25 | Batteries and chargers |
| BIOCOMPATIBILITY | |
|---|---|
| ISO 10993-1 | Evaluation and testing within a risk management process |
The materials used in the subject device are identical composition, formulation processing, and geometry as the materials found in the Extreme X8 Power Wheelchair by Magic Mobility LLC (K211574) and the Quickie Q700-UP M by Sunrise Medical (US) LLC (K172384) device. Furthermore, the T Series Power Wheelchair has the same type and duration of patient contact as the predicate and reference devices. Therefore, based on previous use, the subject device is 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".
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Image /page/11/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. The word "Mobility" is written in a cursive font below the word "magic". The logo is simple and modern, and it is likely used to represent a company that provides mobility solutions.
| SOFTWARE | |
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| IEC 62304 | Software life cycle process |
The results of these tests indicate that the XT Series Power Wheelchair is 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 XT Series Power Wheelchair are assessed to be substantially equivalent to the predicate device.