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
Go Go LX with CTS 3 Wheel	SC50LX	EUDAMEDFDA UDI	Class I	Active
Quantum 4Front 2HD	Quantum 4Front 2HD	EUDAMEDFDA UDI	Class I	Active
Victory XL 140	SC714	EUDAMEDFDA UDI	Class I	Active
Maxima 4 Wheel	SC941	EUDAMEDFDA UDI	Class I	Active
BAJA Wrangler 2 Med	BA401	EUDAMEDFDA UDI	Class I	Active
Pursuit 2	SC7132	EUDAMEDFDA UDI	Class I	Active
Tru Comfort 4 Cushion	Tru Comfort 4 Cushion	EUDAMEDFDA UDI	Class I	Active
Apex Lite 3 Wheel	S39	EUDAMEDFDA UDI	Class I	Active
Jazzy Select 6 2.0	Jazzy Select 6 2.0	EUDAMEDFDA UDI	Class I	Active
Stealth Tru Comfort 2 SPP Cushion	Stealth Tru Comfort 2 SPP Cushion	EUDAMEDFDA UDI	Class I	Active
Q6 Edge Z	Q6 Edge Z	EUDAMEDFDA UDI	Class I	Active
Revo 2.0 3 Wheel	S66	EUDAMEDFDA UDI	Class I	Active
Victory ES 10 4 Wheel	S104	EUDAMEDFDA UDI	Class I	Active
Go Go LX with CTS 4 Wheel	SC54LX	EUDAMEDFDA UDI	Class I	Active
Q6 Edge HD	Q6 Edge HD	EUDAMEDFDA UDI	Class I	Active
Victory ZT	S710ZT	EUDAMEDFDA UDI	Class I	Active
Fusion R40	Fusion R40	EUDAMEDFDA UDI	Class I	Active
Jazzy 600ES	Jazzy 600ES	EUDAMEDFDA UDI	Class I	Active
Sport Back 4 Cushion	Sport Back 4 Cushion	EUDAMEDFDA UDI	Class I	Active
Maxima 3 Wheel	SC901	EUDAMEDFDA UDI	Class I	Active
Zolar	SC614	EUDAMEDFDA UDI	Class I	Active
Kozmo	Kozmo	EUDAMEDFDA UDI	Class I	Active
Jazzy EVO 613	JZEVO613	EUDAMEDFDA UDI	Class I	Active
Quantum 4Front 2	Quantum 4Front 2	EUDAMEDFDA UDI	Class I	Active
BAJA Bandit	BA140	EUDAMEDFDA UDI	Class I	Active
Go Go Super Portable (SC15M)	SC15M	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller LX 4 Wheel	SC44LX	EUDAMEDFDA UDI	Class I	Active
Stealth Zen SP Cushion	Stealth Zen SP Cushion	EUDAMEDFDA UDI	Class I	Active
Cx4	CX4	EUDAMEDFDA UDI	Class I	Active
Cx3	CX3	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller Plus 3 Wheel	SC53	EUDAMEDFDA UDI	Class I	Active
Q6 Edge 3 Stretto	Q6 Edge 3 Stretto	EUDAMEDFDA UDI	Class I	Active
Go Go Elite Traveller Plus 4 Wheel	SC54	EUDAMEDFDA UDI	Class I	Active
Jazzy EVO 613 LI	JZEVO613LI	EUDAMEDFDA UDI	Class I	Active
Go Go Ultra X 3 Wheel	SC40X	EUDAMEDFDA UDI	Class I	Active
Cane/ Crutch Holder	Cane/ Crutch Holder	EUDAMEDFDA UDI	Class I	Active
Q6 Edge 2.0 HD	Q6 Edge 2.0 HD	EUDAMEDFDA UDI	Class I	Active
Pro Seating Coolcore, Active Flex Straps Back (PRO.345)	PRO.345	EUDAMEDFDA UDI	Class I	Active
Q6 Edge 3	Q6 Edge 3	EUDAMEDFDA UDI	Class I	Active
Victory Sport	S710DXW	EUDAMEDFDA UDI	Class I	Active
R-Trak	R-TRAK	EUDAMEDFDA UDI	Class I	Active
Stealth Glacial SP Cushion	Stealth Glacial SP Cushion	EUDAMEDFDA UDI	Class I	Active
Pursuit	SC713	EUDAMEDFDA UDI	Class I	Active

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