510(k) K190337
- Device
- ReWalk Restore
- Applicant
- ReWalk Robotics Ltd.
- 510(k) number
- K190337
- Product code
- PHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-06-03
- Date received
- 2019-02-14
- Regulation
- 890.3480
- Classification name
- Powered Exoskeleton
- Medical specialty
- Physical Medicine
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ofir Koren
- Address
- 3 Hetnufa St., Pob Box-161 Yokneam IL 2069203 2069203
FDA Registration Numbers#
- 3015000676
- 3018091330
- 3009767053
- 3014209670
- 3007615665
- 3011819880
- 3009495988
- 3034724466
Source Documents#
Other 510(k) Records For Product Code PHL #
| 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 |
| K183152 | Phoenix | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018-12-14 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases