FREERIDER, MODEL FR168-4 by FREERIDER USA, INC.

The Freerider Model FR168-4 is a motorized scooter which provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

Device Description

The Freerider Model FR168-4 is a motorized four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable tiller, and a seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be disassembled into five parts for transport in a car trunk. It is provided with a battery charger.

AI/ML Overview

The provided text describes a 510(k) submission for the Freerider™ FR168-4 Electric scooter. However, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such data was not part of this specific submission.

The document indicates that adherence to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995" was the basis for showing substantial equivalence. This type of submission relies on demonstrating that the new device has "technological characteristics" and "use parameters" similar to a legally marketed predicate device (in this case, the Shoprider 114 -TE889).

To be clear, here's a summary based on the provided text's limitations:

A table of acceptance criteria and the reported device performance:
- Not applicable. The submission states that "Comparative performance testing and clinical evaluations were not submitted." The primary "acceptance criteria" for a 510(k) in such cases is demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to relevant guidance documents.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No comparative performance testing or clinical evaluations were submitted, so there is no "test set" in the context of device performance metrics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No test set or ground truth in this context was established from device performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used for device performance evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an electric scooter and not an AI-assisted diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electric scooter and does not involve algorithms for standalone performance evaluation in this manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this 510(k) submission essentially refers to the established safety and effectiveness of the predicate device (Shoprider 114 -TE889) and the engineering tests conducted according to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."
The sample size for the training set:
- Not applicable. This isn't a machine learning/AI device, so there is no concept of a "training set" for performance evaluation.
How the ground truth for the training set was established:
- Not applicable. No training set for performance evaluation was used.

Summary

{0}------------------------------------------------

7/23/97

K971388

510(k) SUMMARY

Freerider USA, Inc. Submitter's Name: 160 N.E. 20th Drive Hillsboro, OR 97124 (503) 640-8924

Date summary prepared:

March 14, 1997

Device name:

Proprietary name: Common or usual name: Classification name:

Freerider™ FR168-4 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.

Legally marketed device for substantial equivalence comparison: Shoprider 114 -TE889 submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) "K920654.

Description of the device:

Intended use of device:

The device provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

Technological characteristics:

The device features and use parameters of the Freerider and Shoprider scooters are very similar. Both are battery operated, have 0.9 horsepower motors, and have regenerative brake systems. Batteries and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the curb climbable by the respective scooters.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, 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}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert S. McQuate, Ph.D. R.S. McQuate & Associates Representing Freerider USA, Inc. 2322 Douqlas Drive Eugene, Oregon 97405

JUL 2 3 1997

Re : K971387 Freerider™ Model FR510-F K971388 Freerider™ Model FR168-4 Requlatory Class: II Product Code: INI Dated: July 9, 1997 Received: July 14, 1997

Dear Dr. McQuate:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, subject to the general controls provisions of the Act. The qeneral 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. ਨੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

{2}------------------------------------------------

Page 2 - Robert S. McQuate, Ph.D.

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as " described in your 510(k) premarket notification. The FDA asboing of substantial equivalence of your devices to legally rinding or bainste devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation Chercred) Missianalig by Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{3}------------------------------------------------

Freerider™ Model FR168-4 - - - - ------510(k) Notification Page 3

Indications for Use Statement

510(k) Number ( if known):

Device name: Freerider FR168-4

Indications for Use:

The Freerider Model FR168-4 is a motorized scooter which provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

(Please do not write below this line)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Aisela

71389

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Regulation Number and Section

§ 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).