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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2025 | WANDERCRAFT SAS Atalante X, Powered Exoskeleton.
Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. Open, Classified |
PHL | K221859 |
| Feb 28, 2020 | Argo Medical Technologies Ltd ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 Terminated |
PHL | K160987 K200032 |
| Aug 14, 2017 | Argo Medical Technologies Ltd ReWalk Personal 6.0. Catalog number: 50-20-0004. Terminated |
PHL | K160987 |
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