FDA.reportPublic FDA data

Capital

Primary DI
00841747183836
Brand
Capital
Company
COLLEGE PARK INDUSTRIES, INC.
Model
CHKA J350
Device description
Capital Hydraulic Knee Assembly, Jet Black, with Pyramid Adapter
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISYJoint, Knee, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISYJoint, Knee, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841747183836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841747183836008417471838368417471838360841747183836

GMDN Terms#

Term, Definition table
TermDefinition
Hydraulic/pneumatic external knee prosthesisA device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., monocentric or polycentric, manual lock, stance flexion) for support during a variety of activities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841747186936Aura PlusAHKA 5002026-01-29
00841747186943Aura PlusAHKA 5502026-01-29
00195411458905IconIC CB G2025-05-28
00841747186912Endoskeletal ComponentsTA WT250 302025-05-28
00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
00841747183973SterlingSLK G3L US12024-11-01
00841747183997SterlingSLK G3C UL22024-11-01
00841747184000SterlingSLK G3C UM+22024-11-01
00841747184017SterlingSLK G3C UM22024-11-01
00841747184024SterlingSLK G3C US22024-11-01
00841747184031SterlingSLK G9L UXL22024-11-01
00841747184048SterlingSLK G9L UL+22024-11-01
00841747184055SterlingSLK G9L UL22024-11-01
00841747184062SterlingSLK G9L UM+22024-11-01
00841747184079SterlingSLK G9L UM22024-11-01
00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
00841747184109SterlingSLK G6L UL+22024-11-01
00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186936Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00841747186943Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00195411458905IconCOLLEGE PARK INDUSTRIES, INC.ISY2025-05-28
00194711121014IntuyWillowwood Global LLCISY2025-03-21
00194711121021IntuyWillowwood Global LLCISY2025-03-21
00713980034377BIOSTEP XTAlps South, LLCISY2025-01-14
04719883460356TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
04719883460370TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
00195411458820IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458837IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458844IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458851IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458868IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00841747186707AuraCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
04719883460004TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460028TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460035TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460059TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460066TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460073TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460110TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460158TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460264TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460271TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460288TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460301TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460318TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460325TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460332TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31