FDA.reportPublic FDA data

LIFEWARD, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097670533009767053LIFEWARD, INC.1Y2026-01-01200 DONALD LYNCH BLVD Marlborough MA US 01752

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850022788383AlterG Anti-Gravity Treadmill - The Neo Anti-Gravity Treadmill is intended to be an entry-level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support1 5102705900AlterG@golifeward.com
00850022788390AlterG Anti-Gravity Treadmill - The Neo+ Anti-Gravity Treadmill is intended to be an entry-level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals who may require or benefit from the use of body weight support1 5102705900AlterG@golifeward.com
00861803000303ReWalk(TM) Personal 6.0 - Powered Exoskeleton - community use+1 (508) 251-1154contact@rewalk.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1537581710170437K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)PHL2025-03-12
1537581854611382K200032ReWalk P6.0PHL2020-05-26
1537581017751272K190337ReWalk RestorePHL2019-06-03
1537581737244778K160987ReWalk(TM)PHL2016-07-22
1537581547678520K072887G-TRAINER MEDICALBXB2008-01-25
1537581058592147DEN130034REWALKPHL2014-06-26
1537581314433395

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHL52025-03-12
BXB12008-01-25

GUDID#

ReWalk 7 Personal Exoskeleton - The 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.

LIFEWARD LTD

2025-04-15