(58 days)
Not Found
No
The summary describes a standard power wheelchair with no mention of AI or ML components or functionalities.
No
Explanation: A power wheelchair is a mobility aid and not typically considered a therapeutic device. Its primary function is to enable movement, not to treat or cure a medical condition.
No
The device description clearly states its function is "providing mobility to persons limited to a sitting position." It is a power wheelchair, not a device used to diagnose medical conditions.
No
The device description clearly states it is a battery-powered, electric motor-driven device with a welded steel frame and components like motors, joystick, seat, armrests, and footrests, indicating it is a physical hardware device.
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 with limited sitting ability. This is a physical function, not a diagnostic one.
- Device Description: The description details a power wheelchair with components like a frame, motors, joystick, seat, etc. These are all related to mobility and transportation, not to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This power wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the X8 power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Extreme 4x4-X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type.
The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows a logo with a spiral design on the left and the words "Innovation In Motion" on the right. The spiral design has small lines radiating outward, resembling a sun. The text is in a simple, sans-serif font, with "Innovation" on the top line and "In Motion" on the bottom line.
PO ROX 507 gola, IN 46703 USA h. 260.665.2769 260.665.3047
510(k) Summary Extreme 4x4-X8 Power Wheelchair Innovation In Motion 510(k) Premarket Notification
APR 1 0 2009
C-1
Applicant's Name, Address, Telephone, Fax, and E-mail information:
Innovation In Motion 201 Growth Parkway P0 Box 507 Angola, IN 46703 Phone: 260.665.2769 Fax: 260.665.3047 E-mail: rick@vestil.com
Preparer's Name, Address, Telephone, Fax, Contact Name, E-mail information, and Date Prepared:
Innovation In Motion 201 Growth Parkway P0 Box 507 Angola, IN 46703 Phone: 260.665.2769 Fax: 260.665.3047 Contact Name: Rick Michael Vice President E-mail: rick@vestil.com Date: February 2009
Manufacturer's Name, Address, Telephone, and Fax Information:
Magic International Pty. Ltd. 2/16 Viewtech Place Rowville, Victoria 3178 Australia Phone: 011.613.9755.8100 Fax: 011.613.9755.8111
1
Image /page/1/Picture/0 description: The image shows a logo with the words "Innovation In Motion". To the left of the text is a spiral design with three lines extending from the left side. The text is in a simple, sans-serif font. The overall design is clean and modern.
PO BOX 507
Angola, IN 46703 USA
Ph. 260.665.2769
F. 260.665.3047
mobility-usa.com
Device Trade, Common, and Classification names:
Device Name: Extreme 4x4- X8
Common Name: Power Wheelchair
Classification Name: Restorative Devices
Predicate Device:
Extreme 4x4- X4 (K000796)
Device Description:
The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type.
The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.
Intended Use:
This device is an electric powered wheelchair for indoor and/or outdoor use, to be used by partially disabled individuals capable of operating a few essential hand controls.
2
ాevice Comparison Table:
COMPARISON TABLE WITH MARKETED DEVICE
··
| K000796 | K000796 | ||
|---|---|---|---|
| X4 | X8 | ||
| Type | Wheelchair, Power | Wheelchair, Power | |
| Intended Use | To provide mobility to persons limited to a | ||
| sitting position, who have the capability of | |||
| operating a power wheelchair | To provide mobility to persons limited to a | ||
| sitting position, who have the capability of | |||
| operating a power wheelchair | |||
| Where Used | Designed to operate indoors and over a | ||
| variety of outdoor surfaces including | |||
| soft/rough terrain with inclines up to 1 in 14 | Designed to operate indoors and over a | ||
| variety of outdoor surfaces including | |||
| soft/rough terrain with inclines up to 1 in 14 | |||
| Design | Compact, rigid | Compact, with front frame articulation | |
| Construction | Steel frame | Steel frame | |
| Dimensions | Overall length: 43.3" | ||
| Overall width: 28" | Overall length: 45.25" | ||
| Overall width: 28" | |||
| Wheel Size | 4 x Ø14" | 4 x Ø14" | |
| Rolling Base Weight | |||
| (No Seat, No | |||
| Batteries) | 159 lbs. | 145 lbs. | |
| Range | 19 miles | 25 miles | |
| Maximum Speed | 5 mph | 6.5 mph | |
| Maximum Weight | |||
| Capacity | 400 lbs | 400lbs | |
| Controller | Dynamic DX-PMB2 electronic control and | ||
| joystick | |||
| *Programmable to meet individual needs | |||
| *Battery charge level gauge | |||
| *Attaches to either side | Dynamic DX2-PMA70L electronic control | ||
| and joystick | |||
| *Programmable to meet individual needs | |||
| *Battery charge level gauge | |||
| *Attaches to either side | |||
| Motors | Four 24V, 4 pole direct drive motors/gearbox | ||
| *Freewheeling lever/motor lock releases and | |||
| engages front and rear motor brakes | Four 24V, 4 pole direct drive gear in line | ||
| motors/gearbox | |||
| *Freewheeling lever/motor lock releases and | |||
| engages rear motor brakes | |||
| Suspension | None | None | |
| Batteries | Two 73 Amp/hour | Two 73 Amp/hour | |
| Seat Width | 16"-24" | 16"-24" | |
| Seating | Upholstery meets California 117 | ||
| specifications for fire retardancy | Upholstery meets California 117 | ||
| specifications for fire retardancy | |||
| Footrest | 1 piece rigid footplate, flip up footplates and | ||
| others | 1 or 2 piece, fixed or flip up, angle and | ||
| height adjustable rigid footplates, and others | |||
| Armrest | Height adjustable, removable | Height adjustable, removable | |
| Safety Features | Electromagnetic brake engaged when chair | ||
| is stationary. When electromagnetic brakes | |||
| are disengaged, chair cannot be driven | Electromagnetic brake engaged when chair | ||
| is stationary. When electromagnetic brakes | |||
| are disengaged, chair cannot be driven | |||
| Drive is inhibited with some seat positioning | |||
| functions |
・・・..
3
Image /page/3/Picture/0 description: The image shows a logo with the words "Innovation In Motion". To the left of the text is a circular design that resembles a sun or a spiral. The text is stacked, with "Innovation" on top and "In Motion" below. The font appears to be handwritten or stylized, giving the logo a unique and informal look.
PO BOX 507 Angola, IN 46703 USA Ph. 260.665.2769 F. 260.665.3047 mobility-usa.com
Substantial Equivalence:
The X8 has the same intended function and use as the X4. The X8 is the next generation of the X4 with minor modifications:
- . Articulated frame for improved obstacle climbing and handling
- High Speed, high torque high efficiency gear in-line motors .
- Latest edition of Dynamic Control electronic software/hardware .
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vestil Manufacturing Coporation % Innovation in Motion Mr. Rick Michael Vice President 201 Growth Parkway Angola, Indiana 46703
Re: K090350
Trade Name: Extreme 4x4 - X8 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 16, 2009 Received: March 20, 2009
Dear Mr. Michael:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
APR 1 0 2009
:
5
Page 2 - Mr. Rick Michael
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: EXTREME 4x4-X8
Indications For Use:
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Prescription Use (Part 21 CFR 301 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
- Page : xi
510(k) Number K