(448 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a mobility scooter designed for transportation and does not claim any therapeutic function or medical treatment.
No
The device description indicates it is a mobility scooter for transportation, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, battery-powered scooter with wheels, brakes, a seat, handlebars, a controller, and batteries, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide transportation for elderly or disabled persons. This is a mobility aid, not a diagnostic tool.
- Device Description: The description details a battery-powered scooter with controls for movement and steering. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of providing information about a person's health status, disease, or condition based on in vitro analysis.
The device is clearly a mobility device designed to assist individuals with transportation.
N/A
Intended Use / Indications for Use
The device provides transportation for an elderly or disabled person. It can be used in a variety of indoor settings.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Freerider FR1 is a battery-powered, four-wheeled scooter intended to provide mobility for elderly or disabled individuals in indoor and outdoor settings. The FR1 is meant to be used by a single rider weighing up to 400 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that can be removed for transport or height adjustment.
The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, an emergency brake, and buttons on the tiller console to control movement of the scooter.
The FR1 has a controller and 2 batteries. The controller is used on a number of other scooters that have been previously cleared. There is also an off-board battery charger, which has also been previously cleared. The specifications of battery charger is same as a predicate device, Heartway powered mobility S-12(K092650).
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
Elderly
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 Testing:
Electromagnetic interference testing was conducted to IEC Standards, RESNA testing to multiple sections of WC-1 and WC-2 was conducted. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR1 passed all testing.
Clinical Testing:
No clinical testing is included in this submission.
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
§ 890.3800 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
FreeRider Corporation Aaron Chang, Operations Manager FreeRider USA 8696 Utica Avenue Rancho Cucamonga, CA 91730
Re: K133187
Trade/Device Name: Freerider FR1, models FR1-13, FR1-15, FR1-17 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: November 21, 2014 Received: December 9, 2014
Dear Mr. Chang:
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. Isting 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); medical device reporting (reporting of medical
1
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 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/Resourcesfor You/Industry/default.htm. 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 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,
Felipe Aquel -S
Carlos Peña, Ph.D., M.S. for
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) K133187
Device Name Freerider FR1, models FR1-13, FR1-15, FR1-17
Indications for Use (Describe)
The device provides transportation for an elderly or disabled person. It can be used in a variety of indoor settings.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summany
1. Contact Details
| Applicant Name : | Freerider Corporation |
|---|---|
| No. 22, Bengong 5th Road | |
| Kang-Shan Dist, Kaohsiung 820, Taiwan |
Contact Name : Michael Chen Freerider Corporation No. 22, Bengong 5th Road Kang-Shan Dist, Kaohsiung 820, Taiwan Phone : 886-7-6223093 Fax : 886-7-6230373
Date Prepared : October 1, 2013
2. Device Name
Trade Name : Freerider FR1
Common Name : Electric scooter
Classification Name : Motorized three-wheeled vehicle; INI; 890.3800
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K092650 | INI | HEARTWAY Power | |
| Mobility Scooter, S12 | HEARTWAY Medical | ||
| Products Co., Ltd. | |||
| K971387 | INI | Freerider FR 510-F | Freerider Corp. |
4. Device Description
The Freerider FR1 is a battery-powered, four-wheeled scooter intended to provide mobility for elderly or disabled individuals in indoor and outdoor settings. The FR1 is meant to be used by a single rider weighing up to 400 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that can be removed for transport or height adjustment.
The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, an emergency brake, and buttons on the tiller console to control movement of the scooter.
5
The FR1 has a controller and 2 batteries. The controller is used on a number of other scooters that have been previously cleared. There is also an off-board battery charger, which has also been previously cleared. The specifications of battery charger is same as a predicate device, Heartway powered mobility S-12(K092650).
5. Intended Use/Indications for use
The FR1 provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
6. Substantial Equivalence Comparison
The FR1 is substantially equivalent to the HEARTWAY Power Mobility Scooter S12 (K092650) and the Freerider FR510-F (K971387)
The device features of the FR1, FR510-F, and the HEARTWAY S12 are very similar. A 11 are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter. Use parameters are very similar. The differences are as follows. The maximum weight that the FR1 can carry is higher and it has a larger turning radius.
7. Non-clinical Testing
Electromagnetic interference testing was conducted to IEC Standards, RESNA testing to multiple sections of WC-1 and WC-2 was conducted. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR1 passed all testing.
8. Clinical Testing
No clinical testing is included in this submission.
9. Technological Characteristics
The device features of the FR1 and its predicate devices, Freerider FR510-F and HEARTWAY S12 are very similar. All are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter. Use parameters are very similar.
There are some differences between the FR1 and the HEARTWAY S12. One is that the FR1 is heavier and it can carry a heavier user. The HEARTWAY S12 does not have anti-tip wheels. The FR1 has three models that vary by travel range. None of these differences raises new issues of safety and effectiveness.
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CONFIDENTIAL
10.Conclusions
The safety and effectiveness of the Freerider FR1 was demonstrated by the testing in compliance with national and international standards. The intended use, basic technology, and many features of the FR1 are similar to the predicate device. No new issues of safety and effectiveness are raised by the differences between the FR1, HEARTWAY S12 and Freerider FR510-F.