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Maxima V, Three Wheel Scooter (Sc900v Maxima V +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091113

by Pride Mobility Products Corp.

Identifiers

510(k) Number
K091113 FDA 510(k)
FDA Product Code
INI FDA 510(k)
Models / Variants
Sc900v Maxima V FDA 510(k)
Four Wheel Scooter FDA 510(k)
Model Sc940v FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3800 FDA 510(k)
Regulation Number
890.3800 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Maxima V is a motorized mobility scooter designed for individuals requiring assisted transportation. Classified as a Vehicle, Motorized 3-Wheeled (and 4-wheeled variant) under FDA nomenclature, it provides powered mobility support for indoor and outdoor use, featuring adjustable seating and ergonomic controls for enhanced user comfort and independence.

Supplied as a reusable, non-sterile device, the Maxima V is intended for home, community, or clinical settings where mobility assistance is required. Models SC900V (three-wheel) and SC940V (four-wheel) support weight capacities up to 500 lbs. and include standard features such as a 22" wide medium-back seat. Authorized under FDA 510K clearance (K091113) as substantially equivalent, compliance with 21 CFR 890.3800 ensures adherence to regulatory standards for motorized mobility devices.

Frequently asked questions

What are the key differences between the three-wheel (SC900V) and four-wheel (SC940V) models of the Maxima V scooter?

The Maxima V comes in two configurations: the SC900V (three-wheel) and SC940V (four-wheel). Both models share core features like a 22-inch wide medium-back seat and a weight capacity of up to 500 lbs., but the primary distinction lies in their wheelbase and stability. The four-wheel SC940V offers enhanced stability for outdoor use or uneven surfaces, while the three-wheel SC900V may be more maneuverable in tighter indoor spaces. Neither model is described as single-use or sterile, as both are reusable and non-sterile devices.

Is the Maxima V scooter intended for clinical, home, or community use, and how does it support users?

The Maxima V is designed for assisted transportation in home, community, or clinical settings, providing powered mobility support for individuals who require assistance. It features adjustable seating and ergonomic controls to improve user comfort and independence, making it suitable for both indoor and outdoor environments where mobility assistance is needed. The device’s FDA clearance (K091113) confirms its compliance for these general use cases.

How is the Maxima V scooter supplied, and what considerations should be made for its maintenance?

The Maxima V is supplied as a reusable, non-sterile device, meaning it is not intended for single-use or sterile procedures. Since it is a motorized mobility scooter, maintenance typically involves routine checks of mechanical components (e.g., tires, brakes, and battery), cleaning to remove debris, and following the manufacturer’s guidelines for longevity. No sterilization is required unless specified for a specific clinical protocol unrelated to the device itself.

What regulatory pathway was followed for the Maxima V’s FDA clearance, and what does that mean for buyers?

The Maxima V received FDA clearance through a 510(k) pathway (K091113), specifically classified as *Substantially Equivalent* under the Physical Medicine advisory committee. This means the device was determined to be as safe and effective as a legally marketed predicate device (a comparable mobility scooter) and complies with 21 CFR 890.3800, the regulatory standard for motorized mobility vehicles. Buyers can rely on this clearance to confirm the device meets FDA requirements for its intended use in assisted transportation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRIDE MOBILITY MAXIMA SC900 OWNER'S MANUAL Pdf Download, Pride Maxima Scooter SC900 Specifications - ManualsLib, PDF MAXIMA -V - Pride Mobility Products Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pride Mobility Products Corp.

Sources (1)

  • FDA 510(k) K091113 24 fields · synced Sep 19, 2026