(21 days)
No
The description focuses on the mechanical and electrical components of a mobility scooter, with no mention of AI or ML capabilities. The "digital programmable Controller" is a common feature in such devices and does not inherently imply AI/ML.
No
The intended use is to provide mobility, not to treat a disease or condition.
No
The provided text describes a mobility scooter designed to aid individuals with limited walking capabilities. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical, battery-operated scooter with various hardware components (seat, tiller, brakes, wheels, battery pack). While it mentions a "digital programmable Controller," this is a component of the physical device, not a standalone software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons with limited walking capabilities or disabled persons. This is a physical aid, not a diagnostic tool.
- Device Description: The description details a battery-operated scooter with features related to mobility, assembly, and safety for physical use. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
- Testing Standards: The listed testing standards (RESNA, ANSI/RESNA, IEC 601-1-1, CAL 117) are related to the safety and performance of mobility devices and electrical equipment, not in vitro diagnostics.
In summary, the Go Go Elite Traveller V / Model SC40EV is a mobility device designed to assist individuals with physical limitations, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.
Product codes
INI
Device Description
The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is a compact battery-operated scooter having a digital programmable Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller V, Three Wheel Scooter is designed for but not limited to Pride Mobility Products Corp. providers / retailers and their consumers, The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or stority the unit.
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
Pride Mobility Products Corp. providers / retailers and their consumers
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:
Compliance to applicable Testing Standards is as follows:
RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed: N/A
Conclusions:
The Go Go Elite Traveller V Model SC40EV, Three Wheel Scooter has the same intended use and similar technological characteristics as the Go Go Mini / Model SC30 (K062160), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not reaisons new questions of safety or effectiveness. Thus, the Go Go Elite Traveller V, Three Wheel Scooter is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
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/0 description: The image contains a handwritten word, "Kogosay". The letters are connected in a cursive style, and the writing appears to be in black ink on a white background. The handwriting is somewhat stylized, with distinct loops and curves forming the letters.
Image /page/0/Picture/1 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, stylized font, with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products, Corp." are written in a smaller, less bold font. The logo is black and white.
MAR 1 9 2009
Research & Developme 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobilitv.com
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Thomas Schappert Official Correspondent
Date Prepared:
02-20-09
Name of Device and Proprietary Name:
Go Go Elite Traveller V / Model SCV40EV, Three Wheel Scooter / Pride Mobility Products Corporation
Common or Usual Name:
Three-Wheel Power Scooter
Classification Name:
Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is substantially equivalent to the Pride Mobility Go Go Mini / Model SC30 (K062160) when comparing, performance, maneuverability, stability, and structure. The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. The differences between The Go Go Mini / Model SC30 (K062160) and the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, are in the front and rear frame construction, weight capacity, and driving range.
1
Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, stylized font with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Device Description:
The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is a compact battery-operated scooter having a digital programmable Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller V, Three Wheel Scooter is designed for but not limited to Pride Mobility Products Corp. providers / retailers and their consumers, The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or stority the unit.
Intended Use:
The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed: N/A
Conclusions:
The Go Go Elite Traveller V Model SC40EV, Three Wheel Scooter has the same intended use and similar technological characteristics as the Go Go Mini / Model SC30 (K062160), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not reaisons new questions of safety or effectiveness. Thus, the Go Go Elite Traveller V, Three Wheel Scooter is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure, representing health and human services.
MAR 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Mr. Thomas Schappert Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643
Re: K090524
Trade Name: Go Go Elite Traveller V/Model SC40EV, Three Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vchicle Regulatory Class: II Product Code: INI Dated: February 20, 2009 Received: February 26, 2009
Dear Mr. Schappert:
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.
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 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); 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.
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Page 2 - Mr. Thomas Schappert
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter
Indications for Use:
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.
Prescription Use X AND / OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off) (Division Division of General, Restorative, and Neurological Devices
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510(k) Number K090524
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