Panels › Physical Medicine › Product code PHL · Class 2
Powered Exoskeleton
Regulation 890.3480
2510(k)s in 12 months (26 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PHL
| Company | 510(k)s | Recalls |
|---|---|---|
| Wandercraft SAS | 4 | 1 |
| Ekso Bionics, Inc. | 4 | 0 |
| Argo Medical Technologies, Inc. | 1 | 2 |
| Cyberdyne, Inc. | 3 | 0 |
| Parker Hannifin Corporation | 3 | 0 |
| Re Walk Robotics , Ltd. | 3 | 0 |
| B-Temia, Inc. | 1 | 0 |
| Exoatlet Asia Co. , Ltd. | 1 | 0 |
| Honda Motor Company, Ltd. | 1 | 0 |
| Rewalk Robotics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K254198 | Trexo Theo Trexo Robotics, Inc., CA | PHL |
| Aug 3, 2026 | K260381 | Eve Wandercraft SAS, FR | PHL |
| Oct 24, 2025 | K250904 | Atalante X Wandercraft SAS, FR | PHL |
| Mar 12, 2025 | K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) Rewalk Robotics Ltd. Dba Lifeward, IL | PHL |
| May 7, 2024 | K233695 | Medical HAL Lower Limb Type (HAL-ML) Cyberdyne, Inc., JP | PHL |
| Dec 13, 2023 | K232077 | Atalante X Wandercraft SAS, FR | PHL |
| Mar 2, 2023 | K221696 | ReWalk P6.0 Re Walk Robotics , Ltd., IL | PHL |
| Dec 29, 2022 | K221859 | Atalante Wandercraft SAS, FR | PHL |
| Jun 9, 2022 | K220988 | EksoNR Ekso Bionics, Inc. | PHL |
| Apr 21, 2022 | K213452 | GEMS-H Samsung Electronics Co., Ltd., KR | PHL |
| Jul 16, 2021 | K201473 | ExoAtlet-II Exoatlet Asia Co. , Ltd. | PHL |
| Oct 2, 2020 | K201559 | HAL for Medical Use(Lower Limb type) Cyberdyne, Inc., JP | PHL |
| Sep 9, 2020 | K201539 | Keeogo Dermoskeleton System B-Temia, Inc., CA | PHL |
| Jun 19, 2020 | K200574 | EksoNR Ekso Bionics, Inc. | PHL |
| May 26, 2020 | K200032 | ReWalk P6.0 Re Walk Robotics , Ltd., IL | PHL |
| Jun 3, 2019 | K190337 | ReWalk Restore Re Walk Robotics , Ltd., IL | PHL |
| Apr 17, 2019 | K183152 | Phoenix Us Bionics, Inc. (Dba Suitx) | PHL |
| Dec 14, 2018 | K181294 | Honda Walking Assist Device Honda Motor Company, Ltd., JP | PHL |
| Jan 31, 2018 | K173530 | Indego(R) Parker-Hannifin Corporation | PHL |
| Dec 17, 2017 | K171909 | HAL for Medical Use (Lower Limb Type) Cyberdyne, Inc., JP | PHL |
| Sep 8, 2017 | K171334 | Indego Parker Hannifin Corporation | PHL |
| Jul 22, 2016 | K160987 | ReWalk(TM) Rewalk Robotics, Inc. | PHL |
| Jul 19, 2016 | K161443 | Ekso (version 1.1) and Ekso GT (version 1.2) Ekso Bionics, Inc. | PHL |
| Apr 1, 2016 | K143690 | Ekso (version 1.1) and Ekso GT (version 1.2) Ekso Bionics, Inc. | PHL |
| Feb 26, 2016 | K152416 | Indego Parker Hannifin Corporation | PHL |
| Jun 26, 2014 | DEN130034 | REWALK Argo Medical Technologies, Inc. | PHL |
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