Data / Medical devices / Israel / Lifeward LTD.
Lifeward LTD.: FDA-registered device maker in Upper Yokneam Northern, Israel, 5 510(k) clearances
Lifeward LTD. is registered with the FDA (registration 3007615665) in Upper Yokneam Northern, Israel. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 12, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007615665
- Address
- 3 Hatnufa St. (6th Floor), Upper Yokneam Northern, Israel, 00206-9203
- Owner or operator
- Lifeward LTD. (10033624)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Remanufacturer, Specification developer
- First device listed
- September 6, 2010
- Registered through
- 2026
- Brand names listed
- AlterG FIT, AlterG M320 Anti-Gravity Treadmill, AlterG NEO Anti-Gravity Treadmill, AlterG NEO+ Anti-Gravity Treadmill, AlterG Treadmill, AlterG VIA, AlterG Via 400, FIT X Anti-Gravity Treadmill; and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Powered | BXB | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Powered Exoskeleton | PHL | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2025 | K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | PHL | Substantially Equivalent | Rewalk Robotics Ltd. Dba Lifeward | accessdata.fda.gov |
| May 26, 2020 | K200032 | ReWalk P6.0 | PHL | Substantially Equivalent | Re Walk Robotics , Ltd. | accessdata.fda.gov |
| June 3, 2019 | K190337 | ReWalk Restore | PHL | Substantially Equivalent | Re Walk Robotics , Ltd. | accessdata.fda.gov |
| July 22, 2016 | K160987 | ReWalk(TM) | PHL | Substantially Equivalent | Rewalk Robotics, Inc. | accessdata.fda.gov |
| June 26, 2014 | DEN130034 | REWALK | PHL | Unknown | Argo Medical Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 28, 2020 | 87818 | Class II | Terminated | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform am | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged. | accessdata.fda.gov |
| August 14, 2017 | 79186 | Class II | Terminated | ReWalk Personal 6.0. Catalog number: 50-20-0004. | Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.