(24 days)
Not Found
No
The description focuses on mechanical and electrical components for mobility, with no mention of AI or ML capabilities.
No.
The device provides mobility assistance, primarily functioning as a mobility aid for disabled persons, rather than actively treating or rehabilitating a medical condition.
No
The device is a mobility scooter designed to provide transportation for disabled individuals, not to diagnose medical conditions. Its intended use and device description focus on mobility, not diagnostic capabilities.
No
The device description clearly outlines a physical, battery-operated scooter with various hardware components (seats, tiller, charger, wheels, etc.) and mentions non-clinical testing related to physical performance and safety standards for wheelchairs and scooters.
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 with limited walking capabilities. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a battery-operated scooter with features related to mobility and user comfort. It does not mention any components or functions 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 the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly a mobility aid, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corporation Maxima V, Three and Four Wheel Scooters 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 Maxima V, Three and Four Wheel Scooters are heavy duty battery-operated scooters. Features include various size removable seats, a foldable tiller, and an off board charger. The Scooter can be disassembled into four parts: the rear section, the front section, batteries, and seat; this allows for ease of use when travelling or storing the scooter. Primary safety features include electronic anti-tip assistance, rear anti-tip wheels, and front anti-tip wheels on the three wheel model.
The Maxima V, Three and Four Wheel Scooters 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
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/1 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 through the middle of the word. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, less stylized font. The logo is black and white.
MAY 1 1 2009
earch & 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 Maxima V – Three and 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:
04-03-09
Name of Device and Proprietary Name:
Maxima V, Three and Four Wheel Scooter / 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 Maxima V, Three and four Wheel Scooters are substantially equivalent to the Pride Mobility Sunrunner SC 400 (K926296), and Sunrunner SC440 (K930953) 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 major differences between Maxima V, Three and Four Wheel Scooters to the Sunrunner SC400 (K926296) and the Sunrunner SC440 (K930953) are in the weight capacity, Charger, and the Control Mechanisms.
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 the letters overlapping each other. Below the word "Pride" is the text "Mobility Products Corp" in a smaller, less bold font.
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Device Description:
Device Description:
The Maxima V, Three and Four Wheel Scooters are heavy duty battery-operated The Maxima V, Three and Tour Wheel Courters. Features include various size removable scoters with programmable Ookloners Free Scooter can be disassembled into
seats, a foldable tiller, and an off board charger. The Scooter can be disable seats, a foldable tiller, and an on board than ben "Tries, and seat; this allows for ease of
four parts: the rear section, the front section, batteries, include electronic four parts. the rear section, the from assisten, batton, safety features include electronic use when travelling of stoning the society. Prear anti-tip wheels, and front anti-tip wheels on the three wheel model.
wheels on the three wheel model.
The Maxima V, Three and Four Wheel Scooters are designed for but her limited to The Maxima V, Three and Tour Whoor Gooders are designed for, but not limited to Stablity, and performanos in mina.
Pride Mobility Products Corp. providers / retailers and their consumers.
Intended Use:
Intended Use of the Pride Mobility Products Corp. Maxima V, Three and Four The Intended use of the Thue Mobility to disabled persons having limited walking capabilities.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
Compliance to applicable Testing Standards is as lones.
RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
(Including Scotlers)
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
Scoters) with Electrical Systems
ANSI/RESNA WC Vol. 2-1998 Section 21 – Requirements and Test Methods for Electromagnetic Compatibility.
Electroniagnetic 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 Maxima V, Three and Four Wheel Scooters have the same intended use and The Maxima V, Three and Tour VMGor Scouters have and Sunrunner SC400 (K926296) and Sunrunner similar technological characteristics as the can the predicate comparisons SC440 (K93095), moreover, the non circlesing and rateristics do not raise any demonstrate that any differences in the tour counting V, Three and Four Wheel hew questions of salely of enectiveness. That, the mannel of the passed all the Scooters are substantially oquivalism.
necessary testing, and are considered to be safe for user operation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Pride Mobility Products Corporation % Mr. Thomas Schappert Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643
MAY 11 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K091113
Trade/Device Name: Maxima V, Three and Four Wheel Scooters Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 10, 2009 Received: April 17, 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 rcclassified 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.
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); 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- Mr. Thomas Schappert
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 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: Maxima V, Three and Four Wheel Scooters
Indications for Use:
The intended use of the Pride Mobility Products Corporation Maxima V, Three The intended ass of the Phas to provide mobility to disabled persons having limited walking capabilities.
AND / OR X Prescription Use (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)
Lullaby
(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices
Page 1 of 1
510(k) Number K091113
i