Goralign PSA 2

Primary DI
00198168267684
Brand
Goralign PSA 2
Company
Impulse Technology, LLC.
Model
GPSA-2QY
Device description
Goralign PSA 2, where “PSA” stands for “Plus Shock Absorber”, is the next generation of ImpulseTechnology's prosthetic ankle that self-adapts to uneven terrain and enhances patient comfort andmotion through its nonlinear stiffness featuring self-adaptation throughout all phases of gait. Theself-adaptive feature helps mitigate gait changes due to terrain and misalignment over time by self-aligning.
Published
2024-06-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198168267684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198168267684001981682676841981682676840198168267684

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external ankle-foot prosthesisA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
814-325-0250customerservice@impulse-technology.com

Regulatory Flags#

DUNS number
078834474
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012673704Goralign PSAGPSA-2TX2024-08-14

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Primary DI, Brand, Company table
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