(9 days)
No
The document describes a standard mobility scooter with a programmable controller and safety features, but there is no mention of AI or ML capabilities. The performance studies focus on compliance with safety standards, not AI/ML performance metrics.
No.
The device is a mobility scooter designed to provide transportation for individuals with limited walking capabilities, not to treat or alleviate a medical condition.
No
The device is 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, battery-operated scooter with various hardware components (frame, wheels, brakes, seat, charger, etc.). While it mentions a "programmable controller," this is a component of the physical device, not a standalone software product.
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 mobility to disabled persons. This is a physical aid, not a diagnostic test performed on biological samples.
- Device Description: The description details a mobility scooter with mechanical and electrical components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological material. There is no mention of diagnostic purposes, disease detection, or monitoring of health conditions through biological analysis.
- Testing Standards: The listed testing standards are related to wheelchairs and electrical systems, not IVD devices.
In summary, the Pride Mobility Products Corporation V Series Scooters are clearly described as mobility aids and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corp. V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.
Product codes
INI
Device Description
The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.
The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
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:
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 V Series Scooters have the same intended use and similar technological characteristics as the Victory Three Wheel Scooter (K072165) and Victory Four Wheel (K071949), 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 V Series Scooters are substantially equivalent to the predicate devices, have passed all necessary testing, and are considered to be safe for user operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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, less stylized font. The logo is black and white.
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 V Series Scooters Three and Four Wheel
APR - 3 2009
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:
03-06-09
Name of Device and Proprietary Name:
V Series Scooters, Three and Four Wheel / Pride Mobility Products Corporation
Common or Usual Name:
Three and Four Wheel Power Scooter
Classification Name:
Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) 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 V Series
1
Image /page/1/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 outline. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, less stylized font. The logo is black and white.
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Scooters to the Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) are in the motors and control mechanisms.
Device Description:
The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.
The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
Intended Use:
The intended use of the Pride Mobility Products Corp. V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.
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 V Series Scooters have the same intended use and similar technological characteristics as the Victory Three Wheel Scooter (K072165) and Victory Four Wheel (K071949), 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 V Series Scooters are substantially equivalent to the predicate devices, have passed all necessary testing, and are 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle faces right and is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
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
APR - 3 2009
Re: K090805
Trade Name: V10, Three Wheel Scooter/Model # SC610V
V10, Three Wheel Scooter/Model # SC610VPS with Power Seat
V10, Four Wheel Scooter/Model # SC710V
V10, Four Wheel Scooter/Model # SC710VPS with Power Seat
Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle
Regulatory Class: II Product Code: INI Dated: March 6, 2009
Received: March 25, 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. Iisting 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 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 N. Melkers 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:
V10, Three Wheel Scooter / Model # SC610V
V10, Three Wheel Scooter / Model # SC610VPS with Power Seat
V10, Four Wheel Scooter / Model # SC710V
V10, Four Wheel Scooter / Model # SC710VPS with Power Seat
Indications for Use:
The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.
Prescription Use AND / OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × (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 | L040808 |
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