(121 days)
Not Found
No
The description focuses on mechanical and electrical components for mobility assistance and does not mention any AI or ML capabilities.
No
The device is a mobility scooter designed to assist individuals with walking difficulties, not to treat or cure a medical condition.
No
This device is a mobility aid (a scooter) designed to help people who have difficulty walking long distances. It does not perform any diagnostic functions or gather diagnostic information about a patient's health condition.
No
The device description clearly outlines physical components like a shell, motor, wheels, and a tiller column, indicating it is a hardware device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The description of the MS 4 Mini Scooter clearly states it is a mobility aid designed to help people with walking difficulties. It is a physical device used for transportation and assistance, not for analyzing biological samples.
- Intended Use: The intended use is to assist individuals who have difficulty walking, not to diagnose or monitor medical conditions through laboratory testing.
The information provided describes a mobility scooter, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
The American Bantex 4 wheeled, MS4 Mini Scooter, has been designed to help people who have a difficult time walking. The user must have use of hand and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS4 Mini scooter is designed for both indoor and outdoor use in clean and dry conditions.
The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
Product codes
INI
Device Description
The American Bantex MS 4 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and two wheel steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 4 breaksdown into several components for easy, tool less assembly, disassembly and transportation. The MS 4 is substantially equivalent in safety, efficacy, technology, and intended use to the Mega 4, marketed by Mega Motions, Inc.
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)
The evaluation and performance verification included performance testing in accordance with ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. The results of such testing as well as, certifications from upholstery testing, functional performance testing, stability (ISO 7176-1 & -2) and electrical immunity testing required by the FDA and European Agencies are included in this submission. The battery charger provided is non-medical grade, for home use only.
The successful testing and comparison has demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
JUL 2 3 2004
AMERICAN BANTEX CORPORATION
1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 10, 2004
Summary of Safety and Effectiveness for the:
| Trade Name: | American Bantex MS 4, Mini Scooter |
|---|---|
| Common Name: | Scooter, 4-wheeled, Powered |
| Classification Number & Name: | 89 INI (890.3800) Vehicle, Motorized 3-Wheeled |
Legally Marketed Predicate Devices for Substantial Equivalence:
*Mega Motion, Inc. - Mega 4 Scooter, K982144
Rationale for SE: The Mega Motion, Mega 4 is a Class II device that is intended to provide assistance and help people lead a more productive and mobile lifestyle. The 4-wheeled scooter provides a stable ride while the two forward wheels steer the scooter. Mega 4 us an outdoor and indoor product that is capable of traveling on bumpy or uneven terrain. The pneumatic tires and sealed transaxle contribute to the quiet operation of the scooter. The Mega 4 has a built-in charger that plugs into a standard 110-120V~ outlet. The dynamic regenerative brake (electric motor) and secondary parking brake are redundant to one another.
Description of Submitted Device:
The American Bantex MS 4 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and two wheel steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 4 breaksdown into several components for easy, tool less assembly, disassembly and transportation. The MS 4 is substantially equivalent in safety, efficacy, technology, and intended use to the Mega 4, marketed by Mega Motions, Inc.
American Bantex affirms that we contract with a fully operational quality manufacturing system, which conforms to the QSR requirements of 21 CFR Part 820, as well as the Quality elements of the European Medical Device Directive, 93/42/EEC for CE Marking. Design History Files are maintained for the development and distribution of products and they are tested using Independent Testing Services prior to marketing them.
1
Intended Uses of the American Bantex MS 4:
The American Bantex 4 wheeled, MS4 Mini Scooter, has been designed to help people who have a difficult time walking. The user must have use of hand and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS4 Mini scooter is designed for both indoor and outdoor use in clean and dry conditions.
Technological Characteristics and Substantial Equivalence:
| Component: | American Bantex MS 4 | Mega Motions, Mega 4 |
|---|---|---|
| Length | 119 cm / 48 inches | 119 cm |
| Width | 61 cm / 24 inches | 24 inches |
| Turning Radius | 107 cm / 42 inches | 42 inches |
| Maximum Speed | 8 Km/h / 5 M/h | 5 M/h |
| Weight Capacity | 120 Kgs / 264 Lbs | 114 Kgs / 264 Lbs |
| Maximum Range | 32-40 Km / 17-21 Miles | 20-25 Miles |
| Battery Type | 2, 12V 32 AH Lead Acid sealed | 2, 12 V 31 AH Lead Acid sealed |
| Brakes | Regenerative and | |
| Electromechanical | Regenerative and | |
| Electromechanical | ||
| Battery Charger | On-board, plug in | On-board |
| 510(k) File Number | Pending this Application | K982144 |
Table 1: Comparison of American Banter, MS 4, to the predicate, Mega Motions, Mega A Scenter
The characteristics, methods of operation, accessories and indication for use are all equivalent to that of the predicate device. The evaluation and performance verification included performance testing in accordance with ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. The results of such testing as well as, certifications from upholstery testing, functional performance testing, stability (ISO 7176-1 & -2) and electrical immunity testing required by the FDA and European Agencies are included in this submission. The battery charger provided is non-medical grade, for home use only.
Conclusion:
The successful testing and comparison has demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Mr. Tracy S. Best American Bantex Corporation 994 North Main St. Bountiful, Utah 84010
Re: K040754
Trade/Device Name: MS 4 Mini Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Codes: INI Dated: July 10, 2004 Received: July 13, 2004
Dear Mr. Best:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Tracy S. Best
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 premated 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milken
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: MS 4 Mini Scooter
Indications for Use:
The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility.
People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter.
The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative. and Neurological Devices
510(k) Number K040754