FDA.reportPublic FDA data

One

Primary DI
00194711301041
Brand
One
Company
Willowwood Global LLC
Model
ONE-TF-SIDE-DUO-3
Catalog number
ONE-TF-SIDE-DUO-3
Device description
WillowWood One TF System, Side Mount LLVS 2 with Alpha Duo Liner Kit, Large Plus
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
IPMCover, Limb
ISPValve, Prosthesis
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1
ISPValve, ProsthesisPhysical Medicine1
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194711301041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194711301041001947113010411947113010410194711301041

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis suspensory component, poweredA powered device intended to be integrated in the socket of an external lower limb prosthesis to provide prosthesis suspension by reducing the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It is designed as a vacuum pump (e.g., electric, mechanical) to provide increased vacuum inside the socket.

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
00194711121014IntuyWW-1LK-1BWW-1LK-1B2025-03-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650532Lumo Socket A-1macu4 GmbHISS2026-07-18
04262429650549Lumo Socket A-2macu4 GmbHISS2026-07-18
04262429650556Lumo Socket A-3macu4 GmbHISS2026-07-18
04262429650624Lumo Socket A-4macu4 GmbHISS2026-07-18
04262429650631Lumo Socket B-1macu4 GmbHISS2026-07-18
04262429650891Lumo Socket B-2macu4 GmbHISS2026-07-18
04262429650907Lumo Socket B-3macu4 GmbHISS2026-07-18
04262429650914Lumo Socket B-4macu4 GmbHISS2026-07-18
04262429650921Lumo Socket C-1macu4 GmbHISS2026-07-18
04262429650938Lumo Socket C-2macu4 GmbHISS2026-07-18
04262429650945Lumo Socket C-3macu4 GmbHISS2026-07-18
04262429650952Lumo Socket C-4macu4 GmbHISS2026-07-18
04262429650969Lumo Socket D-1macu4 GmbHISS2026-07-18
04262429650976Lumo Socket D-2macu4 GmbHISS2026-07-18
04262429650983Lumo Socket D-3macu4 GmbHISS2026-07-18
04262429650990Lumo Socket D-4macu4 GmbHISS2026-07-18
04262429651003Lumo Socket E-1macu4 GmbHISS2026-07-18
04262429651010Lumo Socket E-2macu4 GmbHISS2026-07-18
04262429651027Lumo Socket E-3macu4 GmbHISS2026-07-18
04262429651034Lumo Socket F-1macu4 GmbHISS2026-07-18
04262429651041Lumo Socket F-2macu4 GmbHISS2026-07-18
04262429651058Lumo Socket F-3macu4 GmbHISS2026-07-18
04262429651065Lumo Socket F-4macu4 GmbHISS2026-07-18
04262429651072Lumo Socket E-4macu4 GmbHISS2026-07-18
00636257044988MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046197MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046203MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046210MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046463MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046470MEDIMEDI MANUFACTURING, INC.IPM2025-10-03