FDA.reportPublic FDA data

Intuy

Primary DI
00194711121014
Brand
Intuy
Company
Willowwood Global LLC
Model
WW-1LK-1B
Catalog number
WW-1LK-1B
Device description
Intuy Knee System (ILK), Black Color
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00194711121014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194711121014001947111210141947111210140194711121014

GMDN Terms#

Term, Definition table
TermDefinition
Mechatronic external knee prosthesisA battery-powered electromechanical 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 hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing knee flexion speed and temperature and instantly adjusting motion resistance within a single step. Known as a microprocessor-controlled knee (MPK), it may have various designs and functional features for support during a variety of activities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
740-869-3377xx@xx.xx

Regulatory Flags#

DUNS number
004280723
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194711121021IntuyWW-1LK-1WWW-1LK-1W2025-03-21
00194711300006LimbLogicLL-01220LL-012202025-03-21
00194711300013LimbLogicLL-01240LL-012402025-03-21
00194711300082LimbLogicLLV-01030LLV-010302025-03-21
00194711300099LimbLogicLLV-01041LLV-010412025-03-21
00194711300105LimbLogicLLV-01043LLV-010432025-03-21
00194711300112LimbLogicLLV-01044LLV-010442025-03-21
00194711300129LimbLogicLLV-01045LLV-010452025-03-21
00194711300136LimbLogicLLV-01048LLV-010482025-03-21
00194711300143LimbLogicLLV-01049LLV-010492025-03-21
00194711300150LimbLogicLLV-01050LLV-010502025-03-21
00194711300167LimbLogicLLV-01070LLV-010702025-03-21
00194711300174LimbLogicLLV-01071LLV-010712025-03-21
00194711300181LimbLogicLLV-01080LLV-010802025-03-21
00194711300198LimbLogicLLV-01100LLV-011002025-03-21
00194711300204LimbLogicLLV-02002LLV-020022025-03-21
00194711300211LimbLogicLLV-02003LLV-020032025-03-21
00194711300228LimbLogicLLV-02004LLV-020042025-03-21
00194711300235LimbLogicLLV-02005LLV-020052025-03-21
00194711300242LimbLogicLLV-02006LLV-020062025-03-21

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
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
04719883462688TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31