(15 days)
No
The description focuses on the mechanical and electrical components of a mobility scooter and does not mention any AI or ML capabilities.
No
The device is a mobility scooter designed to provide mobility for individuals with limited walking capabilities, not to diagnose, treat, or prevent a disease or condition.
No
The device is a mobility scooter designed to assist individuals with limited walking capabilities. It does not analyze or interpret medical data for diagnostic purposes.
No
The device description clearly outlines a physical mobility scooter with hardware components such as a battery, motor, seat, tiller, and brakes. While it has a programmable controller, the primary function and description are of a physical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons having limited walking capabilities." This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details a battery-operated scooter with features related to mobility, assembly, and safety for transportation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: 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.
The device is clearly a mobility aid.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller Plus Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
Product codes
INI
Device Description
The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive 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 Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Go Go Elite Traveller Plus, Four 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 storing 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
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
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters)
ANSI/RESNA WC Vol. 2-1998 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
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 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.
NOV 17 2006
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four 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:
10-18-06
Name of Device and Proprietary Name:
Go Go Elite Traveller Plus, Four Wheel Scooter / Pride Mobility Products Corporation
Common or Usual Name:
Four-Wheel Power Scooter
Classification Name:
Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
The Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the Pride Mobility Sunrunner SC-440 (K930953) when comparing comparits. 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 Sunrunner SC-440 (K930953) and the Go Go Elite Traveller Plus, Four Wheel Scooter is in the overall size, front and rear frame construction, and the Control Mechanisms.
$\rightarrow$ mm/s
1
Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a large, bold, sans-serif font, with a horizontal line running through the middle of the word. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, sans-serif font. The logo is black and white.
Device Description:
The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive 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 Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Go Go Elite Traveller Plus, Four 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 storing the unit.
Intended Use:
The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller Plus Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters)
ANSI/RESNA WC Vol. 2-1998 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 Plus, Four Wheel Scooter has the same intended use and similar technological characteristics as the Sunrunner SC-440 (K930953), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the predicate device, has passed all the necessary testing procedures, and is considered to be safe for user operation.
2
Public Health Service
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2006
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643
Re: K063389
Trade/Device Name: Go Go Elite Traveller Plus/Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: ITI Dated: October 18, 2006 Received: November 2, 2006
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.
3
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 10gally marketed predicate device results in a classification for your device and thus, verroits 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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 063389
Device Name: Go Go Elite Traveller Plus / Four Wheel Scooter
Indications for Use:
The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.
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) | |
|---|---|
| -------------------------------------------------------- | -- |
P.K
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number k
$$\alpha$$
3315