Question 1

What types of medical devices does Pride Mobility Products Corporation manufacture?

Accepted Answer

Pride Mobility Products Corporation specializes in mobility-related medical devices, including power wheelchairs, mobility scooters, and travel mobility aids. Their product line also covers specialized seating components like foam cushions (e.g., Stealth Spectrum Foam SPP Cushion) and contour backs (e.g., Pro Seating Coolcore Standard Contour Back), as well as power lift recliners (e.g., Aspen). These devices are designed to assist individuals with limited mobility in daily activities and transportation.

Question 2

Where is Pride Mobility Products Corporation based, and what country regulates its devices?

Accepted Answer

Pride Mobility Products Corporation is headquartered in the United States. While the U.S. FDA regulates its devices under its own framework, the company’s products are also listed in the EUDAMED database, indicating their registration and compliance tracking within the European Union’s medical device regulatory system. This dual presence reflects their global market reach.

Question 3

Which regulatory registries list devices manufactured by Pride Mobility Products Corporation?

Accepted Answer

The devices produced by Pride Mobility Products Corporation are registered and listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry allows healthcare professionals, regulators, and patients to verify the legal status and compliance details of these products within the EU market.

Question 4

How are the mobility devices made by Pride Mobility Products Corporation classified under medical device regulations?

Accepted Answer

All devices manufactured by Pride Mobility Products Corporation fall under Class I classification in the medical device regulatory framework. Class I devices are generally considered to pose the lowest risk and often include items like mobility aids, seating systems, and non-invasive personal mobility solutions. This classification simplifies regulatory oversight while ensuring basic safety and performance standards are met.

Device	Model / Reference	Registries	Class	Status
Stealth Spectrum Foam SPP Cushion	Stealth Spectrum Foam SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore Standard Contour Back (PRO.211)	PRO.211	EUDAMEDFDA UDI	Class I	Active
Go Go Sport 4 Wheel	S74	EUDAMEDFDA UDI	Class I	Active
Stealth Premiere P Cushion	Stealth Premiere P Cushion	EUDAMEDFDA UDI	Class I	Active
Jazzy Passport	Jazzy Passport	EUDAMEDFDA UDI	Class I	Active
Aspen	Aspen	EUDAMEDFDA UDI	Class I	Active
Lunetta Victory Sport (S610DXW)	S610DXW	EUDAMEDFDA UDI	Class I	Active
Jazzy ZTS	Jazzy ZTS	EUDAMEDFDA UDI	Class I	Active
Quantum Rival	Quantum Rival	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller 2 3-Wheel	SC402e	EUDAMEDFDA UDI	Class I	Active
Go Go Endurance LI	S54LXLIT	EUDAMEDFDA UDI	Class I	Active
Apex Lite 4 Wheel	Apex Lite 4 Wheel	EUDAMEDFDA UDI	Class I	Active
Q6 Edge	Q6 Edge	EUDAMEDFDA UDI	Class I	Active
Wrangler	MV600	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller 3 Wheel	SC40E	EUDAMEDFDA UDI	Class I	Active
Quantum 1450	Quantum 1450	EUDAMEDFDA UDI	Class I	Active
Q4	Q4	EUDAMEDFDA UDI	Class I	Active
S613 Luna Victory	SC613 Luna Victory	EUDAMEDFDA UDI	Class I	Active
4Front	4Front	EUDAMEDFDA UDI	Class I	Active
Stealth Simplicity G Cushion	Stealth Simplicity G Cushion	EUDAMEDFDA UDI	Class I	Active
Q6 Edge 2.0	Q6 Edge 2.0	EUDAMEDFDA UDI	Class I	Active
Quantum Outback	Quantum Outback	EUDAMEDFDA UDI	Class I	Active
Stealth Essence SPP Cushion	Stealth Essence SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveler 4 Wheel	SC44E	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore Cushion (PRO.135)	PRO.135	EUDAMEDFDA UDI	Class I	Active
Es13	S713ES	EUDAMEDFDA UDI	Class I	Active
Stealth Essence Plus SPP Cushion	Stealth Essence Plus SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Victory LX Sport	S710LXW	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore Active Standard Back (PRO.315)	PRO.315	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore EPS (Extra Posterior Support) (PRO.511)	(PRO.511)	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller 2 4-Wheel	SC442E	EUDAMEDFDA UDI	Class I	Active
Stealth Solution SPP Cushion	Stealth Solution SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore Cushion (PRO.111)	PRO.111	EUDAMEDFDA UDI	Class I	Active
Jazzy Select 6 PS	Jazzy Select 6 PS	EUDAMEDFDA UDI	Class I	Active
Go Go Endurance AL+	SC54ALX	EUDAMEDFDA UDI	Class I	Active
Q6 Edge 4	Q6 Edge 4	EUDAMEDFDA UDI	Class I	Active
Victory 10 LX with CTS 4 Wheel	S710LX	EUDAMEDFDA UDI	Class I	Active
Go Go Ultra X 4 Wheel	S49	EUDAMEDFDA UDI	Class I	Active
Sparky	Sparky	EUDAMEDFDA UDI	Class I	Active
Victory Twin	SC712	EUDAMEDFDA UDI	Class I	Active
Jazzy Air 2	Jazzy Air 2	EUDAMEDFDA UDI	Class I	Active
Apex Aluma-Lite Plus	AAP4	EUDAMEDFDA UDI	Class I	Active
Victory 10 Deluxe (3 Wheel)	SC610DX	EUDAMEDFDA UDI	Class I	Active
Oxygen Holder	Oxygen Holder	EUDAMEDFDA UDI	Class I	Active
Jazzy Select 6	Jazzy Select 6	EUDAMEDFDA UDI	Class I	Active
Revo 2.0 4 Wheel	S67	EUDAMEDFDA UDI	Class I	Active
Stealth Spectrum Gel SPP Cushion	Stealth Spectrum Gel SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Walker Holder	Walker Holder	EUDAMEDFDA UDI	Class I	Active
Victory 10 DX 2.0	S710DX2	EUDAMEDFDA UDI	Class I	Active
Victory 10 Deluxe (4 wheel)	SC710DX	EUDAMEDFDA UDI	Class I	Active

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