One

Basic Information

• Brand Name: One
• Primary DI: 00194711301195
• Version / Model: ONE-TFVS-MP-S
• Catalog Number: ONE-TFVS-MP-S
• Company Name: Willowwood Global LLC
• Labeler DUNS: 004280723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-21
• Public Version: 1
• Public Version Date: 2025-03-31
• Public Version Status: New
• Public Device Record Key: d944d6f9-135b-440e-b40d-e4fdece657ff

Device Description

One TF System, LimbLogic Side, SmartTemp, Medium Plus

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISP	Valve, Prosthesis	Physical Medicine	890.3420	1
IPM	Cover, Limb	Physical Medicine	890.3025	1
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41536	External limb prosthesis socket liner	A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).	No	Active
64712	External lower-limb prosthesis socket, custom-made	A component of an external lower limb prosthesis designed to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension. A customized socket (shell) is produced for a specific patient using a cast or 3-D anatomical imaging and is manufactured from various materials (e.g., carbon fibre, duroplast, thermoplast, wood, aluminium) either manually or using computer-based techniques. Prefabricated components which provide suspension and stabilization (e.g., liner, sock, valve, sleeve, vacuum pump) are often added to the socket shell to produce a finished socket.	No	Active
64713	External lower-limb prosthesis socket, non-customized	A component of an external lower limb prosthesis designed to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension. This device is supplied as prefabricated components comprising the socket shell and typically suspension components (e.g., liner, sock, valve, lock, cuff, vacuum pump) ready to be assembled, fitted and adjusted to the patient.	No	Active
64716	External lower-limb prosthesis suspensory component, powered	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00194711301195	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]