FDA.reportPublic FDA data

One

Primary DI
00194711301072
Brand
One
Company
Willowwood Global LLC
Model
ONE-TFVD-LG-S
Catalog number
ONE-TFVD-LG-S
Device description
One TF System, LimbLogic Distal, SmartTemp, Large
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
00194711301072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194711301072001947113010721947113010720194711301072

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
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
00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046531MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046548MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046555MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046562MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046579MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046586MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046593MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046609MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046616MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046623MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046630MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046647MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046654MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046661MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046678MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046685MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03