(7 days)
Not Found
No
The device description focuses on mechanical and electrical components typical of a mobility scooter, with no mention of AI or ML technologies.
No
The device is described as providing mobility to disabled persons, which is an assistive function, not a therapeutic one. It does not actively treat, cure, or prevent a disease or condition.
No
The device's intended use is to provide mobility to disabled persons, and the description focuses on its mechanical and electrical components for transportation, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating, 2-Piece Frame, brakes, and wheels. This is a physical mobility device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to disabled persons having limited walking capabilities." This is a physical aid for mobility, not a test performed on samples taken from the human body.
- Device Description: The description details a battery-operated scooter with mechanical and electrical components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or treatment based on laboratory testing.
- Testing Standards: The listed testing standards (RESNA, IEC 601-1-1) are related to the safety and performance of mobility devices and electrical equipment, not in vitro diagnostic testing.
This device is clearly a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corp. Victory XL 130, Four Wheel Scooter / Model # SC713 is to provide mobility to disabled persons having limited walking capabilities.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Victory XL 130, Four Wheel Scooter / Model # SC713 is a Heavy Duty batteryoperated scooter having a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating and 2-Piece Frame. The Victory XL 130 Scooter is equipped with electronic regenerative and electromechanical disc brakes, off-board battery charger, removable 12 Volt 55AH batteries, and anti-tip rear wheels. The scooter has various size foldable Contour seats that are removable. The seat interface is equipped with a clover leaf design allowing for seat rotation and locking at 90° intervals mounted on stationary seat post. The seat is also equipped with sliders for fore-aft adjustment. The Victory XL 130, Four Wheel Scooter / Model # SC713 is designed with ultimate safety, stability, and performance in mind. The scooter is designed for, but not limited to Pride Mobility Products Corporation, 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 Victory XL 130, Four Wheel Scooter / Model # SC713 has the same intended use and similar technological characteristics as the Celebrity XL SC445 (K944939) 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 Victory XL, Four Wheel Scooter / Model # SC713 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
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.
Celebrity XL SC445 (K944939)
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
Pride
Mobility Products Corp.
JUL 1 6 2009
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 Victory Fride Mobility Victory Vicel Scooter / Model #SC713
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Kimberly Blake Official Correspondent
Image /page/0/Picture/23 description: The image shows a solid black circle. The circle is centered on a white background. The circle is a simple geometric shape with no other features.
Date Prepared:
6/16/09
Name of Device and Proprietary Name:
Name of Device and Prophetary Name:
Victory XL 130, Four Wheel Scooter / Model # SC713/ Pride Mobility Products Corporation
Common or Usual Name: Four Wheel Power Scooter
Classification Name: Classincation Names
Physical Medicine / Motorized Three - Wheeled Vehicle
Product Code:
INI
Comparison to Predicate Devices:
Comparison to Predicate Devices:
The Victory XL 130, Four Wheel Scooter / Model # SC713 is substantially equivalent
The Victory XL 130, Four Wheel Scooter / Model #SC445, (K9 The Victory XL 130, Four Wheel SC / Model #8C445 (K944939) when comparing,
to the Pride Mobility Celebrity - Life and structure - The performance characteristics to the Pride Mobility Celebrity AL 7 Model #00=10 (1. s reformance characteristics
performance, maneuverability, stability, and structure, similar to achieve the performance, maneuverability, stablily, and drive mechanisms are similar to achieve the and the position of the electioniss and drive moonline on maintain optimum stablity without
same intended use function that enables the user to maintain optimum (130) Four Wh same intended use function that enables me assets to maintain of AL 130, Four Wheel
hindering performance. The major differences between Victory AL 130, Four Wheel hindering performance. The major unferences between between head.
Scooter / Model # SC713 to the Celebrity XL SC445 (K944939) are in the Control Mechanisms.
Image /page/0/Picture/21 description: The image shows a black circle on a white background. The circle is located in the upper portion of the image. The bottom of the circle is cut off by the edge of the image.
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 word. Below the word "Pride" is the text "Mobility Products Corp." 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 Victory XL 130, Four Wheel Scooter / Model # SC713 is a Heavy Duty batteryoperated scooter having a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating and 2-Piece Frame. The Victory XL 130 Scooter is equipped with electronic regenerative and electromechanical disc brakes, off-board battery charger, removable 12 Volt 55AH batteries, and anti-tip rear wheels.
The scooter has various size foldable Contour seats that are removable. The seat interface is equipped with a clover leaf design allowing for seat rotation and locking at 90° intervals mounted on stationary seat post. The seat is also equipped with sliders for fore-aft adjustment.
The Victory XL 130, Four Wheel Scooter / Model # SC713 is designed with ultimate safety, stability, and performance in mind. The scooter is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
Intended Use:
The intended use of the Pride Mobility Products Corp. Victory XL 130, Four Wheel Scooter / Model # SC713 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 Victory XL 130, Four Wheel Scooter / Model # SC713 has the same intended use and similar technological characteristics as the Celebrity XL SC445 (K944939) 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 Victory XL, Four Wheel Scooter / Model # SC713 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
Image /page/1/Picture/18 description: The image shows the text "2 of 2". This likely indicates that it is the second page of a two-page document. The text is written in a simple, sans-serif font. The background is plain white.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a simple, bold, sans-serif font. The text is arranged on a single line. The words are clearly legible and the overall impression is clean and straightforward.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Ms. Kimberly Blake Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643
JUL 1 6 2009
Re: K092088
Trade/Device Name: Victory XL 130, Four Wheel Scooter/Model # SC713 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 19, 2009 Received: July 9, 2009
Dear Ms. Blake:
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 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 or any I 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 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.
3
Page 2 - Ms. Kimberly Blake
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 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 Director Division of Surgical, Orthopedic, and Restorative 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: Victory XL 130, Four Wheel Scooter / Model # SC713
Indications for Use:
The intended use of the Pride Mobility Products Corporation Victory XL 130, Four The intended use of the hobility to provide mobility to disabled persons having limited walking capabilities.
AND / OR Prescription Use X (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)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
$10(k) Number K092088
19(k) Number