| Primary Device ID | 00860001744514 |
| NIH Device Record Key | 55ce17ed-11cc-4100-8f96-8417590e557b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReWalk 7 Personal Exoskeleton |
| Version Model Number | ReWalk 7 |
| Catalog Number | 50-20-0005 |
| Company DUNS | 533320867 |
| Company Name | LIFEWARD 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001744514 [Primary] |
| PHL | Powered Exoskeleton |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2025-04-15 |
| 00860001744521 - ReWalk 7 Personal Exoskeleton Therapist Handheld Device | 2025-09-25 ReWalk 7 Personal Exoskeleton Therapist Handheld Device Wireless, web connected therapist handheld device (THD) is used by certi |
| 00860001744514 - ReWalk 7 Personal Exoskeleton | 2025-04-23The ReWalk 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community. Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control. All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use. The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs. |
| 00860001744514 - ReWalk 7 Personal Exoskeleton | 2025-04-23 The ReWalk 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals a |