(125 days)
Not Found
No
The device description explicitly states it does not introduce any new technology or material that departs from current industry standard or practice, and there are no mentions of AI, DNN, or ML.
No
The device is a powered wheelchair designed to provide mobility, but it does not treat or prevent a medical condition, nor does it restore a bodily function in a therapeutic way.
No
This device is an electric wheelchair designed to provide mobility, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is an "electric indoor/outdoor wheelchair" and describes physical components like a "four wheel drive wheelchair with a controller attached to the armrest," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to people who are unable to walk. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is an electric wheelchair, designed for physical movement and transportation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
To provide mobility to people who are unable to walk and are capable of operating a powered wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Cajun Commando 4x4 is an electric indoor/outdoor wheelchair. The Cajun Commando is similar in design, composition and function to the Magic Mobility Extreme 4x4-8. The Cajun Commando 4x4 does not introduce any new technology or material that departs from current industry standard or practice. The Cajun Commando 4x4 is a four wheel drive wheelchair with a controller attached to the armrest allowing the rider to control the movement of the chair.
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)
Non-clinical data demonstrate that the Commando 4x4 is as safe, as effective, and performs as well as the Extreme X8. The device was tested against the following standards:
WC-1:2009 American National Standard for Wheelchairs- Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1-Determination of Static Stability
WC-2:2009 American National Standard for Wheelchairs- Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 2- Determination of Dynamic Stability of Electrically Powered Wheelchairs
WC-2:2009 American National Standard for Wheelchairs- Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 3: Determination of Effectiveness of Brakes
WC-2:2009 Section 4: Energy Consumption of Electrically Powered Wheelchairs and Scooters for Determination of Theoretical Distance Range
WC-1:2009 American National Standard for Wheelchairs- Volume 1: Requirements and Test Methods for Wheelchairs (including scooters) Section 5- Determination of Dimensions, Mass, and Maneuvering Space
WC-2:2009 American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 6: Determination of Maximum Speed, Acceleration and Deceleration of Electrically Powered Wheelchairs
WC-1:2009 American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions
WC-1:2009 American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
WC-2:2009 American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 9: Climatic Tests for Electrically Powered Wheelchairs
WC-2:2009 American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 10: Determination of Obstacle-Climbing Ability of Electrically Powered Wheelchairs
WC-2:2009 American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs-Requirements And Test Methods
WC-2:2009 American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) With Electrical Systems Section 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
Lil Critter, LLC Brenda Brant President 2701 Oliver Road Monroe, Louisiana 71201
Re: K152672
Trade/Device Name: Cajun Commando 4x4 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 21, 2015 Received: December 24, 2015
Dear Brenda Brant:
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. 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 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152672
Device Name Cajun Commando 4x4
Indications for Use (Describe)
To provide mobility to people who are unable to walk and are capable of operating a powered 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image shows a logo for Cajun Mobility. The logo features a cartoon lobster on the left side of the image. To the right of the lobster, the word "CAJUN" is written in red, and below that, the word "MOBILITY" is written in black.
A Division of Lil Critter, LLC
510(k) Summary Cajun Commando 4x4 Lil Critter, LLC 510(k) K152672 Traditional
| Applicant's Name: | Lil Critter, LLC |
|---|---|
| Physical Address: | 2701 Oliver Road |
| Monroe, LA 71201 | |
| Mailing Address: | 2703 Stokes Street |
| Monroe, LA 71201 | |
| Phone: | 318.366.5772 |
| Contact Person: | Brenda Brant |
| President | |
| Email: | cajunmobility@aol.com |
| Date: | January 20, 2016 |
| Device Name: | Cajun Commando 4x4 |
| Device Name: | Cajun Commando 4x4 |
|---|---|
| Common Name: | Powered Wheelchair |
| Classification Name: | Wheelchair, Powered |
| Product Code: | ITI |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 890.3860 |
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Image /page/4/Picture/0 description: The image shows the logo for Cajun Mobility, which is "A Division of Lil Critter, LLC". The logo features a cartoon crawfish with googly eyes and a large claw. The words "CAJUN" are in red, and the word "MOBILITY" is in black.
Predicated Device: Extreme 4x4-X8 Power Wheelchair K090350
Device Description:
The Cajun Commando 4x4 is an electric indoor/outdoor wheelchair. The Cajun Commando is similar in design, composition and function to the Magic Mobility Extreme 4x4-8. The Cajun Commando 4x4 does not introduce any new technology or material that departs from current industry standard or practice. The Cajun Commando 4x4 is a four wheel drive wheelchair with a controller attached to the armrest allowing the rider to control the movement of the chair.
Intended Use:
To provide mobility to people who are unable to walk and are capable of operating a powered wheelchair.
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Image /page/5/Picture/0 description: The image shows a logo for Cajun Mobility, a division of Lil Critter, LLC. The logo features a cartoon crawfish with googly eyes and a large claw. The words "CAJUN MOBILITY" are written in red and black, respectively, next to the crawfish. The text "A Division of Lil Critter, LLC" is written in black below the main logo.
Substantial Equivalence Discussion
The Commando 4x4 is the next generation of the Extreme X8 and has the same intended function and use as the Extreme X8.
The Cajun Commando is similar in design, composition and function to the Extreme 4x4-8. The Cajun Commando 4x4 does not introduce any new technology or material that departs from current industry standard or practice.
There are no differences in subject device or predicated device that effect safety or effectiveness.
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Comparison Chart Substantial Equivalence
| | Extreme 4x4- X8 K090350 | Cajun Commando 4x4
K140704 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Wheelchair, power | Wheelchair, power |
| Indications for Use | To provide mobility to persons
limited to a sittingposition, who
have the capacity of operating a
powered wheelchair. | To provide mobility to people who
are unable to walk & are capable
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 as
well as outdoors in firm terrain
with inclines up to 1 in 14 |
| Design | Compact, with front frame
articulation | Rugged steel design with
conventional wheelchair steering |
| Construction | Steel Frame | Steel Frame |
| Dimensions | Overall length: 45.25"
Overall height: 37" | Overall length: 57" with rear anti-
tip
Overall height: 41.5" |
| Wheelchair Seat Height | 19" | 19.7" |
| Wheel Size | 4x 14" | 4x 14.6" |
| Wheelchair Turning Radius | 52" | 38" |
| Rolling Base Weight (without seat
& batteries) | 145 lbs | 149 lbs |
| Range | 15.5 miles | 11.8 miles (max) |
| Maximum Speed | 6.2 miles | 6.6 mph |
| Maximum Weight capacity | 400 lbs | 350 lbs |
| Ground Clearance | 4" | 4.5" |
| Controller | Dynamic DX2-PMA70L electronic
control and joystick
*programmable to meet individual
needs *battery charge level gauge
*attaches to either side | Dynamic DX2-PMA90 electronic
control and joystick
*programmable to meet individual
needs *battery charge level gauge
*attaches to either side |
| Motors | 4-24V, 4 pole direct drive gear in
line motors/gearbox
*Freewheeling lever/motor lock
releases & engages rear motor
brakes | 4-24V,4 pole direct drive gear in
line motors/gearbox
*Freewheeling lever/ motor lock
release & engages all motor
brakes |
| Suspension | None | None |
| Batteries | 2- 73 AMP/hour AGM Group 24
12 volt Weight 55 lbs | 2-80 AMP/hour AGM Group 24
12 volt
Weight 49.2 lbs |
| Battery Charger Input Voltage | 110 volt | 110 volt |
| Type of Braking System | Electromagnetic,regenerative
brakes with a free-wheeling mode | Electromagnetic, regenerative
brakes with a free-wheeling mode |
| Seat Width | 16" – 24" | 18" – 22" |
| Footrest | 1 or 2 piece, fixed or flip up, angle and height adjustable rigid 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. Drive is inhibited with some seat positioning functions. | Electromagnetic brake engaged when chair is stationary. When electromagnetic brakes are disengaged, chair cannot be driven. |
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Discussion of Non-Clinical Data
| WC-1:2009 | American National Standard for Wheelchairs- Volume 1:
Requirements and Test Methods for Wheelchairs (including
Scooters) Section 1-Determination of Static Stability |
|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| WC-2:2009 | American National Standard for Wheelchairs- Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 2- Determination of Dynamic
Stability of Electrically Powered Wheelchairs |
| WC-2:2009 | American National Standard for Wheelchairs- Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 3: Determination of
Effectiveness of Brakes |
| WC-2:2009 | Section 4: Energy Consumption of Electrically Powered
Wheelchairs and Scooters for Determination of
Theoretical Distance Range |
| WC-1:2009 | American National Standard for Wheelchairs- Volume 1:
Requirements and Test Methods for Wheelchairs
(including scooters) Section 5- Determination of Dimensions,
Mass, and Maneuvering Space |
| WC-2:2009 | American National Standard for Wheelchairs – Volume 2:
Additional Requirements for Wheelchairs (including scooters) |
| | With Electrical Systems Section 6: Determination of
Maximum Speed, Acceleration and Deceleration of
Electrically Powered Wheelchairs |
| WC-1:2009 | American National Standard for Wheelchairs – Volume 1:
Requirements and Test Methods for Wheelchairs (including
Scooters) Section 7: Method of Measurement of Seating and
Wheel Dimensions |
| WC-1:2009 | American National Standard for Wheelchairs – Volume 1:
Requirements and Test Methods for Wheelchairs (including
Scooters) Section 8: Requirements and Test Methods for
Static, Impact and Fatigue Strengths |
| WC-2:2009 | American National Standard for Wheelchairs – Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 9: Climatic Tests for
Electrically Powered Wheelchairs |
| WC-2:2009 | American National Standard for Wheelchairs – Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 10: Determination of
Obstacle-Climbing Ability of Electrically Powered Wheelchairs |
| WC-2:2009 | American National Standard for Wheelchairs – Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 14: Power and Control
Systems for Electrically Powered Wheelchairs-Requirements
And Test Methods |
| WC-2:2009 | American National Standard for Wheelchairs – Volume 2:
Additional Requirements for Wheelchairs (including scooters)
With Electrical Systems Section 21: Requirements and Test
Methods for Electromagnetic Compatibility of Electrically
Powered Wheelchairs and Motorized Scooters |
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Image /page/10/Picture/0 description: The image shows a logo for "Cajun Mobility, A Division of Lil Critter, LLC". The logo features a cartoon crawfish with googly eyes and a large claw. The words "Cajun Mobility" are written in a large, red font, with "Mobility" stacked below "Cajun". The text "A Division of Lil Critter, LLC" is written in a smaller, black font below the main logo.
Substantial Equivalence Conclusion
The proposed Cajun Commando 4x4 power wheelchair has similar indications for use as the predicate Extreme X8 power wheelchair. The subject and predicate have the same intended function and similar technological characteristics.
There are technological differences between the subject and predicate devices, however, the results of performance testing demonstrate that these differences do not raise any questions of safety or effectiveness.
The nonclinical data demonstrate that the Commando 4x4 is as safe, as effective, and performs as well as the Extreme X8.
Therefore, the Cajun Commando 4x4 is substantially equivalent to the predicate device.