FDA Product Code
FDA Product Code PHL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.3480
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026-09-02 | Traditional | PDF ↗ |
| K260381 | Eve | Wandercraft SAS | 2026-08-03 | Traditional | PDF ↗ |
| K250904 | Atalante X | Wandercraft SAS | 2025-10-24 | Traditional | PDF ↗ |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 | Traditional | PDF ↗ |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024-05-07 | Traditional | PDF ↗ |
| K232077 | Atalante X | Wandercraft SAS | 2023-12-13 | Traditional | PDF ↗ |
| K221696 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2023-03-02 | Traditional | PDF ↗ |
| K221859 | Atalante | Wandercraft SAS | 2022-12-29 | Traditional | PDF ↗ |
| K220988 | EksoNR | Ekso Bionics, Inc. | 2022-06-09 | Traditional | PDF ↗ |
| K213452 | GEMS-H | Samsung Electronics Co., Ltd. | 2022-04-21 | Traditional | PDF ↗ |
| K201473 | ExoAtlet-II | Exoatlet Asia Co. , Ltd. | 2021-07-16 | Traditional | PDF ↗ |
| K201559 | HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. | 2020-10-02 | Traditional | PDF ↗ |
| K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | 2020-09-09 | Traditional | PDF ↗ |
| K200574 | EksoNR | Ekso Bionics, Inc. | 2020-06-19 | Traditional | PDF ↗ |
| K200032 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2020-05-26 | Traditional | PDF ↗ |
| K190337 | ReWalk Restore | Re Walk Robotics , Ltd. | 2019-06-03 | Traditional | PDF ↗ |
| K183152 | Phoenix | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 | Traditional | PDF ↗ |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018-12-14 | Traditional | PDF ↗ |
| K173530 | Indego(R) | Parker-Hannifin Corporation | 2018-01-31 | Traditional | PDF ↗ |
| K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017-12-17 | Traditional | PDF ↗ |
| K171334 | Indego | Parker Hannifin Corporation | 2017-09-08 | Traditional | PDF ↗ |
| K160987 | ReWalk(TM) | Rewalk Robotics, Inc. | 2016-07-22 | Special | PDF ↗ |
| K161443 | Ekso (version 1.1) and Ekso GT (version 1.2) | Ekso Bionics, Inc. | 2016-07-19 | Traditional | PDF ↗ |
| K143690 | Ekso (version 1.1) and Ekso GT (version 1.2) | Ekso Bionics, Inc. | 2016-04-01 | Traditional | PDF ↗ |
| K152416 | Indego | Parker Hannifin Corporation | 2016-02-26 | Traditional | PDF ↗ |
| DEN130034 | REWALK | Argo Medical Technologies, Inc. | 2014-06-26 | Direct | — |
Product code PHL · Class II · Physical Medicine. Data: openFDA.