| Primary Device ID | 00861803000327 |
| NIH Device Record Key | d5127bca-bdfc-4fbb-8c9b-ec0943c19799 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReWalk(TM) Rehabilitaiton |
| Version Model Number | 50-30-0001 |
| Company DUNS | 533320867 |
| Company Name | REWALK ROBOTICS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 (508) 251-1154 |
| contact@rewalk.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861803000327 [Primary] |
| PHL | Powered Exoskeleton |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-08 |
| 00860001744507 - ReStore | 2019-10-24 The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions |
| 00861803000303 - ReWalk(TM) Personal 6.0 | 2018-07-06 Powered Exoskeleton - community use |
| 00861803000327 - ReWalk(TM) Rehabilitaiton | 2018-07-06Powered Exoskeleton - rehabilitation institution use |
| 00861803000327 - ReWalk(TM) Rehabilitaiton | 2018-07-06 Powered Exoskeleton - rehabilitation institution use |
| 00861803000310 - ReWalk(TM) Personal | 2018-03-29 Powered exoskeleton - community use |