(78 days)
No
The description focuses on the mechanical and electrical components of a mobility scooter and does not mention any AI or ML capabilities.
No
The device is described as a mobility aid to help people with difficulty walking or unable to walk long distances. It does not provide treatment or therapy for a disease or condition.
No
The device description and intended use indicate it is a mobility aid for walking difficulties, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a body (shell), motor, wheels, and a tiller column, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "help people who have a difficult time walking" and "provide assistance to individuals that are unable to walk long distances." This describes a mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a scooter with a motor, wheels, steering, and a shell. This aligns with a physical mobility device.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the MS 3 Mini Scooter is a mobility device, not an IVD.
N/A
Intended Use / Indications for Use
The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The MS 3 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 3 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 single wheeled 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 3 breaks-down into several components for easy, tool less assembly, disassembly and transportation. The MS 3 is substantially equivalent in safety, efficacy, technology, and intended use to the Mega 3, 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)
PROCEDURE: For Running Speed Test:
The EUT was set up according to fully operation. The Speed Meter put on the Equipment Under Test (EUT)'s wheel. Let EUT runs 50 meter to find a max speed data.
For Break Test:
Let EUT running with fully speed for 10 meter and release the controller. After the EUT stop, measure the distance between the stop point and release controller point.
For Acceleration & Deceleration:
Use A=V/T equation to find the data. A=acceleration rate; V=meter; T=Second2
RESULTS: The EUT meets the requirements, There was no performance degradation detected during this test.
CHANGES OR MODIFICATIONS: There were no modifications performed by test personnel.
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
OCT 2 1 2004
AMERICAN BANTEX CORPORATION
1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 30, 2004
Summary of Safety and Effectiveness for the:
| Trade Name: | American Bantex MS 3, Mini Scooter |
|---|---|
| Common Name: | Scooter, 3-wheeled, Powered |
| Classification Number & Name: | 89 INI (890.3800) Vehicle, Motorized 3-Wheeled |
Legally Marketed Predicate Devices for Substantial Equivalence:
*Mega Motion, Inc. - Mega 3 Scooter. K982145
Rationale for SE: The Mega Motion, Mega 3 is a Class II device that is intended to provide assistance and help people lead a more productive and mobile lifestyle. The 3-wheeled scooter provides a stable ride while the single forward wheel steers the scooter. Mega 3 is 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 3 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 3 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 single wheeled 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 3 breaks-down into several components for easy, tool less assembly, disassembly and transportation. The MS 3 is substantially equivalent in safety, efficacy, technology, and intended use to the Mega 3, marketed by Mega Motions, Inc.
American Bantex affirms that we contract with a fully operational quality manufacturing system, which conforms to the OSR requirements of 21 CFR Part 820, as well as the Quality clements of the Furopean Medical Device Directive, 93/42/FIEC 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.
Summary of Safety and Effectiveness
Page 1 of 1
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1
ATTACHMENT - SUMMARY MATRIX
| PROCEDURE: | For Running Speed Test: |
|---|---|
| The EUT was set up according to fully operation. The Speed Meter put on the | |
| Equipment Under Test (EUT)'s wheel. Let EUT runs 50 meter to find a max | |
| speed data. | |
| For Break Test: | |
| Let EUT running with fully speed for 10 meter and release the controller. After | |
| the EUT stop, measure the distance between the stop point and release | |
| controller point. | |
| For Acceleration & Deceleration: | |
| Use A=V/T equation to find the data. A=acceleration rate; V=meter; T=Second2 | |
| RESULTS: | The EUT meets the requirements, There was no performance degradation |
| detected during this test. | |
| CHANGES OR | |
| MODIFICATIONS: | There were no modifications performed by test personnel. |
| Test Equipment | Manufacturer | Model No. | Last Cal. | Cal. Due | |||
|---|---|---|---|---|---|---|---|
| Speed Meter | SMART | Q809-09(18) | 08/16/2003 | 08/16/2004 | |||
| Note: All testing were performed using internationally recognized standards. All test instruments were | |||||||
| calibrated and traosable to the National Institute of Standards and Technology (NIST). |
All parameters relating to wheelchair motion are controlled by the VSI (joystick) controller which was tested with the device as submitted as part of the 510(k).
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2004
American Bantex Corporation C/o Mr. Tracy S. Best Regulatory Affairs Consultant 994 North Main Street Bountiful, Utah 84010
Re: K042104
Trade/Device Name: MS 3 Mini Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 4, 2004 Received: October 7, 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 recaral 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 he 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
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 Office of Compliance at (240) 276-0120. 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 Manufacturers, 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 Millman
Celia M. Witten, Ph.D., M.D. 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 3 Mini Scooter
Indications for Use:
The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The THE MO 3 Mini Socctor and upper-body mobility.
People who have some mobility, but cannot walk for long distances or people that may need r copic who halk will generally purchase this scooter.
The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
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 D valuation (ODE)
Mark N. Mcllhenser
Restorative. and Neurological De
510(k) Number K042104