Product code PHL
- Device name
- Powered Exoskeleton
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.3480
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250904 | Atalante X | Wandercraft SAS | 2025-10-24 |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024-05-07 |
| K232077 | Atalante X | Wandercraft SAS | 2023-12-13 |
| K221696 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2023-03-02 |
| K221859 | Atalante | Wandercraft SAS | 2022-12-29 |
| K220988 | EksoNR | Ekso Bionics, Inc. | 2022-06-09 |
| K213452 | GEMS-H | Samsung Electronics Co., Ltd. | 2022-04-21 |
| K201473 | ExoAtlet-II | Exoatlet Asia Co. , Ltd. | 2021-07-16 |
| K201559 | HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. | 2020-10-02 |
| K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | 2020-09-09 |
| K200574 | EksoNR | Ekso Bionics, Inc. | 2020-06-19 |
| K200032 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2020-05-26 |
| K190337 | ReWalk Restore | Re Walk Robotics , Ltd. | 2019-06-03 |
| K183152 | Phoenix | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018-12-14 |
| K173530 | Indego(R) | Parker-Hannifin Corporation | 2018-01-31 |
| K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017-12-17 |
| K171334 | Indego | Parker Hannifin Corporation | 2017-09-08 |
| K160987 | ReWalk(TM) | Rewalk Robotics, Inc. | 2016-07-22 |
| K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016-07-19 |
| K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016-04-01 |
| K152416 | Indego | Parker Hannifin Corporation | 2016-02-26 |
| DEN130034 | REWALK | Argo Medical Technologies, Inc. | 2014-06-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03665965000167 | Atalante X | WANDERCRAFT | 2026-05-13 |
| 04560340091435 | Medical HAL Lower Limb Type | CYBERDYNE, INC. | 2026-04-22 |
| 00860001744521 | ReWalk 7 Personal Exoskeleton Therapist Handheld Device | LIFEWARD LTD | 2025-09-17 |
| B168501100000 | Indego | Ekso Bionics, Inc. | 2025-07-01 |
| B168501110001 | Indego Therapy | Ekso Bionics, Inc. | 2025-07-01 |
| 00860001744514 | ReWalk 7 Personal Exoskeleton | LIFEWARD LTD | 2025-04-15 |
| 18800140400031 | ExoAtlet®-II | COSMO ROBOTICS CO., Ltd. | 2025-01-17 |
| 00860003478776 | TraumaGuard Intra-abdominal Pressure-Sensing System | SENTINEL MEDICAL TECHNOLOGIES | 2024-07-06 |
| 00860003478738 | TraumaGuard Intra-abdominal Pressure-Sensing System | SENTINEL MEDICAL TECHNOLOGIES | 2024-07-06 |
| 00860003478714 | TraumaGuard Intra-abdominal Pressure-Sensing System | SENTINEL MEDICAL TECHNOLOGIES | 2024-07-06 |
| 03665965000129 | Atalante X | WANDERCRAFT | 2023-03-13 |
| B168EKSONR0 | EksoNR | Ekso Bionics, Inc. | 2022-03-03 |
| B168EKSOGT0 | EksoGT | Ekso Bionics, Inc. | 2022-03-03 |
| 07540162060007 | KEEOGO - CLINICIAN KIT | B-Temia Inc | 2021-06-16 |
| 00860001744507 | ReStore | LIFEWARD LTD | 2019-10-16 |
| 04560340090940 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340091091 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340091084 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340091077 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340091060 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340090971 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340090964 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| 04560340090957 | HAL for Medical Use | CYBERDYNE, INC. | 2019-02-01 |
| M704501110001 | Indego Therapy | Ekso Bionics, Inc. | 2018-08-27 |
| B1431200000 | Ekso | Ekso Bionics, Inc. | 2016-09-23 |
| M704501100000 | Indego | Ekso Bionics, Inc. | 2016-09-15 |
| 00861803000303 | ReWalk(TM) Personal 6.0 | LIFEWARD LTD | 2016-09-08 |
| 00861803000310 | ReWalk(TM) Personal | LIFEWARD LTD | 2016-09-08 |
| 00861803000327 | ReWalk(TM) Rehabilitaiton | LIFEWARD LTD | 2016-09-08 |