(58 days)
No
The summary describes a standard mobility scooter with basic electronic controls and does not mention any AI or ML components or functionalities.
No.
The device is described as a mobility scooter providing transportation for elderly or disabled individuals, not as a device intended to treat or cure any medical condition.
No
Explanation: The device description clearly states its purpose is to provide transportation and mobility for elderly or disabled persons, which is not a diagnostic function. There is no mention of it being used to identify or determine the presence of a disease or condition.
No
The device description clearly outlines a physical, battery-powered scooter with mechanical and electrical components, not solely software.
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 individuals. This is a mobility aid, not a diagnostic test performed on biological samples.
- Device Description: The description details a battery-powered scooter with features for mobility and control. It does not mention any components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to reagents, assays, or diagnostic measurements.
- Performance Studies: The performance studies focus on safety, electromagnetic compatibility, and mechanical testing related to mobility devices (ISO 7176 standards are specific to wheelchairs and scooters). There are no studies related to diagnostic accuracy or clinical performance in a diagnostic context.
In summary, the FR-L05 (Luggie Super) is clearly described as a mobility device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
Product codes
INI
Device Description
The FR-L05 (Luggie Super) is a battery-powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-L05 (Luggie Super) is meant to be used by a single rider weighing up to 360 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that has several height adjustments. 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, and speed knobs on the tiller console to control movement speed of the scooter.
The FR-L05 (Luggie Super) has a controller and 1 lithium battery. 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 specification of battery charger is the same as the predicate device, Freerider Luggie FR168-4(IT) (K110165).
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" patient
Intended User / Care Setting
"elderly or disabled person" / variety of indoor and outdoor settings.
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
Non-clinical Testing: Electromagnetic interference testing was conducted to IEC 6100-4-2, IEC 6100-4-3, IEC 6100-4-8, EN 12184:2009, EN 55011:2010, and EN55022. ISO 7176 testing to multiple sections; Section 1, Section 2, Section 4, Section 5, Section 6, Section 7, Section 8, Section 9, Section 10, Section 13, Section 14, Section 14, Section 15, Section 16, and Section 21 was conducted. As well as ISO 10993 and IEC60601-1. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR-L05 (Luggie Super) passed all testing.
Clinical Testing: No clinical testing is included in this submission.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Freerider Corporation c/o Michael Chen R&D Department and Assistant Vice President No. 22, Bengong 5th Road Kang-Shan Dist Kaohsiung City, 820, Taiwan, R.O.C.
Re: K151944
Trade/Device Name: Luggie Super Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: May 31, 2015 Received: July 14, 2015
Dear Mr. Chen:
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 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,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151944
Device Name Luggie Super
Indications for Use (Describe)
The FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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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: May 31, 2015
2. Device Name
Trade Name: Luggie Super
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 |
|---|---|---|---|
| K110165 | INI | Freerider FR 168-4(IT) | Freerider Corp. |
| Luggie |
4. Device Description
The FR-L05 (Luggie Super) is a battery-powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-L05 (Luggie Super) is meant to be used by a single rider weighing up to 360 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that has several height adjustments. 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, and speed knobs on the tiller console to control movement speed of the scooter.
The FR-L05 (Luggie Super) has a controller and 1 lithium battery. The controller is used
4
Freerider FR-L05(Luggie Super) 510(k) Notification
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 specification of battery charger is the same as the predicate device, Freerider Luggie FR168-4(IT) (K110165).
5. Intended Use/Indications for use
The FR-L05 (Luggie Super) 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 FR-L05 is substantially equivalent to the Freerider Luggie FR168-4(IT) (K110165).
The device features of the FR-L05 and the Luggie FR168-4(IT) (K110165) are very similar. Both 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 difference are as follows. The maximum weight that the FR-L05 can carry is greater, the spacing between the wheels is wider, and that it has a bigger seat.
7. Non-clinical Testing
Electromagnetic interference testing was conducted to IEC 6100-4-2, IEC 6100-4-3, IEC 6100-4-8, EN 12184:2009, EN 55011:2010, and EN55022. ISO 7176 testing to multiple sections; Section 1, Section 2, Section 4, Section 5, Section 6, Section 7, Section 8, Section 9, Section 10, Section 13, Section 14, Section 14, Section 15, Section 16, and Section 21 was conducted. As well as ISO 10993 and IEC60601-1. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR-L05 (Luggie Super) passed all testing.
8. Clinical Testing
No clinical testing is included in this submission.
9. Technological Characteristics
The device features of the FR-L05 and the FR168-4(IT) (K110165) are very similar. Both 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 FR-L05 and the FR168-4(IT) (K110165). One is that the FR-L05 is heavier and it can carry a heavier user. Widening of the base to get a better stability. None of these differences raises new issues of safety and effectiveness.
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10.Conclusion
The safety and effectiveness of the FR-L05 (Luggie Super) was demonstrated by the testing in compliance with national and international standards. The intended use, basic technology, and many features of the FR-L05 are similar to the predicate device. No new issues of safety and effectiveness is raised by the differences between the FR-L05 and FR168-4(IT) (K110165).