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
TruStep	TS RBALX 27W D3	FDA UDI	Class I	Active
TruStep	TS RJALX 25N D9	FDA UDI	Class I	Active
Voyager	VY RJEN 27 D2	FDA UDI	Class I	Active
Odyssey iQ	OD iQ LTEN 26 D5	FDA UDI	Class I	Active
Soleus	SO LJP 28N D34	FDA UDI	Class I	Active
Soleus	SO LBS 30W D12	FDA UDI	Class I	Active
TruStep	TS LJEN 26N D2	FDA UDI	Class I	Active
Accent	AC LCIPM 24W D2	FDA UDI	Class I	Active
Endoskeletal Components	TA WT250 30	FDA UDI	Class I	Active
Terrain iW	TN iW EN 24 D3	FDA UDI	Class I	Active
Aviator	AV LCEN 24 D1	FDA UDI	Class I	Active
Orbit	OR LBEN 23 D2	FDA UDI	Class I	Active
TruStep	TS LCALX 27N D7	FDA UDI	Class I	Active
TruStep	TS LBALX 25W D9	FDA UDI	Class I	Active
Onyx	OX LJDF 27W D53	FDA UDI	Class I	Active
Soleus	SO RTT 28N D34	FDA UDI	Class I	Active
Scout	SC RM 16 D1	FDA UDI	Class I	Active
Scout	SC RBM 22 D2	FDA UDI	Class I	Active
Soleus	SO RS 30 D53	FDA UDI	Class I	Active
Soleus	SO RM 27 D55	FDA UDI	Class I	Active
Velocity	VL RJMEN 26W D6	FDA UDI	Class I	Active
Terrain iW	TN iW RCEN 26 D1	FDA UDI	Class I	Active
Soleus	SO RTP 25N D75	FDA UDI	Class I	Active
Soleus	SO LM 25 D75	FDA UDI	Class I	Active
Terrain	TN RTEN 22 D3	FDA UDI	Class I	Active
Onyx	OX LTDF 29W D11	FDA UDI	Class I	Active
Venture	V LBEN 30W D5	FDA UDI	Class I	Active
Venture	V RJALX 26W D1	FDA UDI	Class I	Active
TruStep	TS RCEN 26W D2	FDA UDI	Class I	Active
Soleus	SO LP 23 D33	FDA UDI	Class I	Active
Venture	V RBEN 30N D2	FDA UDI	Class I	Active
Velocity	VL RMEN 26 D4	FDA UDI	Class I	Active
TruStep	TS RBALX 24W D4	FDA UDI	Class I	Active
Onyx	OX LCDM 28N D21	FDA UDI	Class I	Active
Onyx	OX LBDM 28N D43	FDA UDI	Class I	Active
Soleus	SO RBM 22N D54	FDA UDI	Class I	Active
Accent	AC LCD4M 24N D2	FDA UDI	Class I	Active
Accent	AC LBDML 27N D3	FDA UDI	Class I	Active
TruStep	TS LALX 26 D1	FDA UDI	Class I	Active
TruStep	TS RTALX 23N D3	FDA UDI	Class I	Active
Tribute	TB RCEN 23N D3	FDA UDI	Class I	Active
Accent	AC RCIPM 25N D1	FDA UDI	Class I	Active
Soleus	SO RCT 24W D12	FDA UDI	Class I	Active
Soleus	SO LJT 26N D34	FDA UDI	Class I	Active
Soleus	SO LCS 26W D33	FDA UDI	Class I	Active
Soleus	SO LCS 22N D12	FDA UDI	Class I	Active
Venture	V RBEN 28N D4	FDA UDI	Class I	Active
Terrain	TN LJEN 30 D4	FDA UDI	Class I	Active
Soleus	SO RTT 29N D54	FDA UDI	Class I	Active
Soleus	SO RS 21 D34	FDA UDI	Class I	Active

COLLEGE PARK INDUSTRIES, INC.

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