Question 1

What types of medical devices does College Park Industries, Inc. manufacture?

Accepted Answer

College Park Industries, Inc. specializes in external ankle-foot prostheses, which are artificial limbs designed to replace the ankle and foot for individuals with lower-limb amputations. Their product line includes mechanical, mechatronic, and hydraulic/pneumatic ankle-foot prostheses, as well as structural and alignment components for prosthetic systems. These devices are intended to restore mobility and function for users.

Question 2

Where is College Park Industries, Inc. based, and where are their devices developed?

Accepted Answer

College Park Industries, Inc. is based in the United States. Their devices are designed, manufactured, and distributed from this location, ensuring compliance with U.S. regulatory standards and quality control processes.

Question 3

Which regulatory registries or databases list College Park Industries’ devices?

Accepted Answer

College Park Industries’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, ensuring transparency and traceability in the medical device supply chain.

Question 4

How are College Park Industries’ devices classified by regulatory authorities?

Accepted Answer

The FDA classifies College Park Industries’ devices as Class I. This classification typically applies to devices that pose minimal risk to users, such as certain external prostheses, and generally requires less regulatory oversight compared to higher-risk devices.

Question 5

What is the purpose of the external ankle-foot prostheses manufactured by College Park Industries?

Accepted Answer

The external ankle-foot prostheses from College Park Industries are designed to replicate the function of a natural ankle and foot, enabling users to walk, stand, and perform daily activities with improved mobility and stability. These devices are tailored to accommodate different gait patterns, terrains, and user needs, including mechanical, adaptive, and terrain-specific models.

Device	Model / Reference	Registries	Class	Status
Tempo	TO LTEN 28 D2	FDA UDI	Class I	Active
Tribute	TB LBEN 25W D1	FDA UDI	Class I	Active
Velocity	VL RCMEN 28W D4	FDA UDI	Class I	Active
Terrain iW	TN iW RBEN 27 D1	FDA UDI	Class I	Active
Onyx	OX LTDF 28N D31	FDA UDI	Class I	Active
Venture	V RBEN 22N D1	FDA UDI	Class I	Active
TruStep	TS RTEN 30N D8	FDA UDI	Class I	Active
TruStep	TS LBEN 22N D3	FDA UDI	Class I	Active
Breeze	BE LTEN 29 D3	FDA UDI	Class I	Active
Soleus	SO RTT 25N D12	FDA UDI	Class I	Active
Odyssey iQ	OD iQ RCEN 25 D5	FDA UDI	Class I	Active
Soleus	SO LBS 29W D33	FDA UDI	Class I	Active
Onyx	OX LCDF 25W D31	FDA UDI	Class I	Active
Soleus	SO RBP 22N D11	FDA UDI	Class I	Active
Tribute	TB LCENS 26 D4	FDA UDI	Class I	Active
Soleus	SO RCT 30N D32	FDA UDI	Class I	Active
Soleus	SO RG 24 D33	FDA UDI	Class I	Active
Soleus	SO LBS 26N D55	FDA UDI	Class I	Active
Soleus	SO LBS 22N D32	FDA UDI	Class I	Active
Velocity	VL LJMEN 28W D1	FDA UDI	Class I	Active
Odyssey iQ	OD iQ RCEN 25 D1	FDA UDI	Class I	Active
Terrain	TN LTEN 30 D4	FDA UDI	Class I	Active
Onyx	OX LJDF 27W D11	FDA UDI	Class I	Active
Soleus	SO RTS 30W D34	FDA UDI	Class I	Active
Soleus	SO RCP 24W D33	FDA UDI	Class I	Active
Soleus	SO LBT 26W D33	FDA UDI	Class I	Active
TruStep	TS RTEN 27N D1	FDA UDI	Class I	Active
Onyx	OX LTD4 28N D53	FDA UDI	Class I	Active
Onyx	OX LJD4 25W D11	FDA UDI	Class I	Active
Tribute	TB RJEN 22N D2	FDA UDI	Class I	Active
Venture	V RJALX 29W D4	FDA UDI	Class I	Active
Accent	AC RBDFL 25N D2	FDA UDI	Class I	Active
Tribute	TB RTEN 24W D2	FDA UDI	Class I	Active
Soleus	SO LBG 29N D11	FDA UDI	Class I	Active
TruStep	TS RCEN 29N D7	FDA UDI	Class I	Active
Onyx	OX RCDF 29W D54	FDA UDI	Class I	Active
Soleus	SO LJM 29N D55	FDA UDI	Class I	Active
Accent	AC RBDFM 26W D2	FDA UDI	Class I	Active
Soleus	SO LP 22 D34	FDA UDI	Class I	Active
Accent	AC RBD4M 23W D3	FDA UDI	Class I	Active
TruStep	TS RTALX 30W D2	FDA UDI	Class I	Active
Venture	V LCALX 24N D5	FDA UDI	Class I	Active
Onyx	OX LCD4 28N D42	FDA UDI	Class I	Active
Hoizon HD	HZ LJEN 26 D3	FDA UDI	Class I	Active
Truper	TP LCEN 19 D2	FDA UDI	Class I	Active
Aviator	AV RCEN 27 D2	FDA UDI	Class I	Active
Onyx	OX RTDF 24N D43	FDA UDI	Class I	Active
Soleus	SO RTP 30W D55	FDA UDI	Class I	Active
Soleus	SO LBG 24N D55	FDA UDI	Class I	Active
Aviator	AV RCEN 30 D1	FDA UDI	Class I	Active

COLLEGE PARK INDUSTRIES, INC.

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