Goralign PSA

Basic Information

• Brand Name: Goralign PSA
• Primary DI: 00860012673704
• Version / Model: GPSA-2TX
• Company Name: Impulse Technology, LLC.
• Labeler DUNS: 078834474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-14
• Public Version: 1
• Public Version Date: 2024-08-22
• Public Version Status: New
• Public Device Record Key: cf77cb72-e922-4054-bf4b-6c5bb2a97b5f

Device Description

Goralign PSA is a self-adaptive prosthetic ankle component. It is integrated with and in between a prosthetic foot and a pylon or socket. Goralign PSA 2, where “PSA” stands for “Plus Shock Absorber”, is the next generation of Impulse Technology's prosthetic ankle that self-adapts to uneven terrain and enhances patient comfort and motion through its nonlinear stiffness featuring self-adaptation throughout all phases of gait. The self-adaptive feature helps mitigate gait changes due to terrain and misalignment over time by self-aligning.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64723	Mechanical-resistance external ankle-foot prosthesis	A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012673704	GS1

Customer Contacts

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