(19 days)
Not Found
No
The description focuses on standard mobility scooter features and safety mechanisms, with no mention of AI or ML capabilities. The "programmable 70-amp Digital Controller" likely refers to basic electronic control, not advanced AI/ML algorithms.
No.
The scooter is intended to provide mobility to persons with limited walking capabilities, which is a supportive function, not a therapeutic treatment for a medical condition.
No
The device is described as a mobility scooter designed to provide transportation for individuals with limited walking capabilities, not to diagnose medical conditions.
No
The device description clearly outlines a physical scooter with hardware components like a controller, seat, tiller, brakes, and wheels. It is not solely software.
Based on the provided information, the Pride Mobility Products Corporation Victory Four Wheel Scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to persons with limited walking capabilities. This is a physical aid for mobility, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a battery-operated scooter with features related to mobility, safety, and portability. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document 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 screening of diseases or conditions.
- Performance Studies: The performance studies listed are related to safety and testing standards for wheelchairs and electrical systems, not diagnostic accuracy or performance on biological samples.
In summary, the Victory Four Wheel Scooter is a mobility device, not a diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Victory Four Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital 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 Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
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/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a stylized font, with a thick black line running horizontally through the middle of the word. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, simpler font. The logo is black and white.
AUG - 1 2007
Image /page/0/Picture/2 description: The image shows the letterhead for Research & Development. The address is 182 Susquehanna Ave, Exeter, PA 18643. The phone number is 570-655-5574, and the fax number is 655-2990. The website is www.pridemobility.com.
Device Description:
The Victory Four Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital 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 Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.
Intended Use:
The intended use of the Pride Mobility Products Corp. Victory Four Wheel Scooter is to provide mobility to persons having limited walking capabilities.
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 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Victory Four Wheel Scooter has the same intended use and similar technological characteristics as the Legend SC340 (K930952), moreover, the nonclinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. TThus, the Victory Four Wheel Scooter is substantially equivalent to the predicate device, has passed all testing requirements, and is considered to be safe for user operation.
1
Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is in a large, bold font, with a horizontal line running through the middle of the letters. Below the word "Pride" is the text "Mobility Products Corp." in a smaller font. The logo is black and white.
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Victory 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:
06-29-07
Name of Device and Proprietary Name:
Victory 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 Victory Four Wheel Scooter is substantially equivalent to the Pride Mobility SC340 (K930952) when comparing components, performance, Legend 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 Legend SC340 (K930952) and the Victory Four Wheel Scooter are in the wheelbase, front and rear frame construction, and the Control Mechanisms.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, PA 18643
AUG - 1 2007
K071949 Re:
Trade/Device Name: Victory Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 7, 2007 Received: August 12, 2007
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. 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
3
Page 2 – Mr. Thomas Schappert
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 n your 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
00
Enclosure
4
Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Victory Four Wheel Scooter
Indications for Use:
The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND / OR | |
| 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K071949 |
|---|---|
| --------------- | --------- |
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