| Primary Device ID | 00860012673704 |
| NIH Device Record Key | cf77cb72-e922-4054-bf4b-6c5bb2a97b5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Goralign PSA |
| Version Model Number | GPSA-2TX |
| Company DUNS | 078834474 |
| Company Name | Impulse Technology, LLC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012673704 [Primary] |
| ISH | Component, External, Limb, Ankle/Foot |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-22 |
| Device Publish Date | 2024-08-14 |
| 00860012673704 - Goralign PSA | 2024-08-22Goralign 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. |
| 00860012673704 - Goralign PSA | 2024-08-22 Goralign PSA is a self-adaptive prosthetic ankle component. It is integrated with and in between a prosthetic foot and a pylon o |
| 00198168267684 - Goralign PSA 2 | 2024-07-02 Goralign PSA 2, where “PSA” stands for “Plus Shock Absorber”, is the next generation of Impulse Technology's prosthetic |