(254 days)
Not Found
Not Found
No
The description details a standard motorized scooter with no mention of AI or ML features. The performance studies reference a 1995 guidance document, further indicating a lack of advanced AI/ML technology.
No.
The document states that the device provides "transportation for an elderly or disabled person" and does not describe any therapeutic function such as treating or preventing a disease or condition.
No
Explanation: The device is described as a motorized scooter for transportation, not for diagnosing any medical condition. Its intended use and description clearly indicate it is a mobility aid.
No
The device description clearly outlines physical hardware components like wheels, a platform, tiller, seat, battery, and charger, indicating it is a physical device, not software-only.
Based on the provided information, the Freerider Model Luggie is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for providing transportation to elderly or disabled individuals. This is a mobility aid, not a diagnostic test performed on biological samples.
- Device Description: The description details a motorized scooter with wheels, a tiller, and a seat. This is a mechanical device for physical movement, not equipment for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies mentioned relate to the mechanical and powered aspects of the vehicle, not diagnostic accuracy or analytical performance.
Therefore, the Freerider Model Luggie falls under the category of a mobility aid or powered wheelchair/scooter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Freerider Model Luggie is a motorized three wheeled scooter which is battery operated. It consists of a platform which connects the three wheels, an adjustable tiller, and seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be simply folds under five steps into one unit for transport in a car trunk. It is provided with a battery & a battery charger.
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)
Tests listed in the Guidance Document for the preparation of market Notification [510(k)] Applications for Mechanical and powered wheelchairs, and Motorized Three Wheeled Vehicles, July1995, were conducted and the results included in the subject 510(k) submission. Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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.
Not Found
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
§ 890.3800 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
510(k) SUMMARY
Submitter's Name: JEFFREY L DAVIS
SEP 3 0 2011
FreeRider Corporation No.22, Bengong 510 Road, Kang-Shan Town Kaohsiung County 820, Taiwan
NOVEMEBR 15st, 2010 Date summary prepared Device name:
Proprietary name: Common or usual name: Classification name:
Electric scooter Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.
Legally marketed device for substantial equivalence comparison:
Tzora Active Systems Ltd –Easy Travel Elite submitted by Tzore Active Systems , Inc, Kibbutz , Tzora
Freerider Luggie
Description of the device:
The Freerider Model Luggie is a motorized three wheeled scooter which is battery operated. It consists of a platform which connects the three wheels, an adjustable tiller, and seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be simply folds under five steps into one unit for transport in a car trunk. It is provided with a battery & a battery charger.
Intended use of device:
The device provides transportation for an elderly or disabled person. It can be used in variety of indoor and outdoor settings.
Technological characteristics:
The device features and use parameters of the Freerider and Tzora scooters are very similar. Both are battery operated, have 0.1 horsepower motors, and have regenerative brake systems. Batteries capacity and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective scooters.
Testing conducted:
Tests listed in the Guidance Document for the preparation of market Notification [510(k)] Applications for Mechanical and powered wheelchairs, and Motorized Three Wheeled Vehicles, July1995, were conducted and the results included in the subject 510(k) submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
SEP 30 2011
FreeRider Luggie Scooters. Inc. % Diagnostic Medical Consultant Mr. Jeffrey L. Davis 4500 Country Glen Court Riverside, CA 92505
Re: K110165
Trade/Device Name: FreeRider Luggie Regulation Number: 21 CFR 890,3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 24, 2011 Received: August 24, 2011
Dear Mr. Davis:
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 contractly ability warranties. We remind you, however, that device labeling must be truthful and not micheading.
!f 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You must
2
Page 2 - Mr. Jeffrey L. Davis
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 (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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Freerider TM Model Luggie ' ' 510(k) Notification Page 4
Indications for Statement
KI10165 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________
Device name: Freerider Luggie
Indications for Use:
The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings. -
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Divis Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110165
Prescription Use_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Over-The-Counter Use_ OR
( Per 21 CFR 801.109)