PHL
25 FDA 510(k) clearances · Product code
172 daysmedian time to decision
374 days90th percentile
25clearances measured
FDA profile
- Official device name
- Powered Exoskeleton
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3480
- Medical specialty
- Physical Medicine
- FDA definition
- A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.
- Adverse events (MAUDE)
- 2018: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Eve (K260381) | Wandercraft SAS | 2026-08-03 |
| Atalante X (K250904) | Wandercraft SAS | 2025-10-24 |
| ReWalk® 7 Personal Exoskeleton (50-20-0005) (K241822) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 |
| Medical HAL Lower Limb Type (HAL-ML) (K233695) | Cyberdyne, Inc. | 2024-05-07 |
| Atalante X (K232077) | Wandercraft SAS | 2023-12-13 |
| ReWalk P6.0 (K221696) | Re Walk Robotics , Ltd. | 2023-03-02 |
| Atalante (K221859) | Wandercraft SAS | 2022-12-29 |
| EksoNR (K220988) | Ekso Bionics, Inc. | 2022-06-09 |
| GEMS-H (K213452) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| ExoAtlet-II (K201473) | Exoatlet Asia Co. , Ltd. | 2021-07-16 |
| HAL for Medical Use(Lower Limb type) (K201559) | Cyberdyne, Inc. | 2020-10-02 |
| Keeogo Dermoskeleton System (K201539) | B-Temia, Inc. | 2020-09-09 |
| EksoNR (K200574) | Ekso Bionics, Inc. | 2020-06-19 |
| ReWalk P6.0 (K200032) | Re Walk Robotics , Ltd. | 2020-05-26 |
| ReWalk Restore (K190337) | Re Walk Robotics , Ltd. | 2019-06-03 |
| Phoenix (K183152) | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 |
| Honda Walking Assist Device (K181294) | Honda Motor Company, Ltd. | 2018-12-14 |
| Indego(R) (K173530) | Parker-Hannifin Corporation | 2018-01-31 |
| HAL for Medical Use (Lower Limb Type) (K171909) | Cyberdyne, Inc. | 2017-12-17 |
| Indego (K171334) | Parker Hannifin Corporation | 2017-09-08 |
| ReWalk(TM) (K160987) | Rewalk Robotics, Inc. | 2016-07-22 |
| Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (K161443) | Ekso Bionics, Inc. | 2016-07-19 |
| Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (K143690) | Ekso Bionics, Inc. | 2016-04-01 |
| Indego (K152416) | Parker Hannifin Corporation | 2016-02-26 |
| REWALK (DEN130034) | Argo Medical Technologies, Inc. | 2014-06-26 |
Track PHL automatically
Every clearance here is in the API, with alerts when new ones post.