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Data / Medical devices / United States / Lifeward, Inc.

Lifeward, Inc.: FDA-registered device maker in Hudson, MA, United States, 6 510(k) clearances

Lifeward, Inc. is registered with the FDA (registration 3009767053) in Hudson, MA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009767053
Address
2 Cabot Rd, Suite 104, Hudson, MA, United States, 01749
Owner or operator
Lifeward, Inc. (10043289)
Roles
Complaint file establishment
First device listed
February 3, 2013
Registered through
2026
Brand names listed
AlterG FIT, FIT X Anti-Gravity Treadmill, AlterG M320 Anti-Gravity Treadmill, AlterG NEO Anti-Gravity Treadmill, AlterG NEO+ Anti-Gravity Treadmill, AlterG VIA, VIA X Anti-Gravity Treadmill, AlterG Via 400, Via 400M, Via 400X Anti-Gravity Treadmill, ReStore, ReWalk Personal and more

Devices it lists

DeviceProduct codeClassRoleSource
Exerciser, PoweredBXB1Complaint file establishmentaccessdata.fda.gov
Powered ExoskeletonPHL2Complaint file establishmentaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2025K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)PHLSubstantially EquivalentRewalk Robotics Ltd. Dba Lifewardaccessdata.fda.gov
May 26, 2020K200032ReWalk P6.0PHLSubstantially EquivalentRe Walk Robotics , Ltd.accessdata.fda.gov
June 3, 2019K190337ReWalk RestorePHLSubstantially EquivalentRe Walk Robotics , Ltd.accessdata.fda.gov
July 22, 2016K160987ReWalk(TM)PHLSubstantially EquivalentRewalk Robotics, Inc.accessdata.fda.gov
June 26, 2014DEN130034REWALKPHLUnknownArgo Medical Technologies, Inc.accessdata.fda.gov
January 25, 2008K072887G-TRAINER MEDICALBXBSubstantially EquivalentAlter-G, Inc.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.