FDA.reportPublic FDA data

ReStore

Primary DI
00860001744507
Brand
ReStore
Company
LIFEWARD LTD
Model
50-40-0001
Device description
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
Published
2019-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PHLPowered Exoskeleton

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHLPowered ExoskeletonPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190337000ReWalk RestoreRe Walk Robotics , Ltd.2019-06-03PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001744507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001744507008600017445078600017445070860001744507

GMDN Terms#

Term, Definition table
TermDefinition
Programmable ambulation exoskeleton, clinicalA battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533320867
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001744521ReWalk 7 Personal Exoskeleton Therapist Handheld DeviceReWalk 7 THD30-30-08242025-09-17
00860001744514ReWalk 7 Personal ExoskeletonReWalk 750-20-00052025-04-15
00861803000303ReWalk(TM) Personal 6.050-20-00042016-09-08
00861803000310ReWalk(TM) Personal50-20-00022016-09-08
00861803000327ReWalk(TM) Rehabilitaiton50-30-00012016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665965000167Atalante XWANDERCRAFTPHL2026-05-13
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.PHL2026-04-22
00860001744521ReWalk 7 Personal Exoskeleton Therapist Handheld DeviceLIFEWARD LTDPHL2025-09-17
B168501100000IndegoEkso Bionics, Inc.PHL2025-07-01
B168501110001Indego TherapyEkso Bionics, Inc.PHL2025-07-01
00860001744514ReWalk 7 Personal ExoskeletonLIFEWARD LTDPHL2025-04-15
18800140400031ExoAtlet®-IICOSMO ROBOTICS CO., Ltd.PHL2025-01-17
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
00860003478776TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
03665965000129Atalante XWANDERCRAFTPHL2023-03-13
B168EKSOGT0EksoGTEkso Bionics, Inc.PHL2022-03-03
B168EKSONR0EksoNREkso Bionics, Inc.PHL2022-03-03
07540162060007KEEOGO - CLINICIAN KITB-Temia IncPHL2021-06-16
04560340090940HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090957HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090964HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090971HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091060HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091077HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091084HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091091HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
M704501110001Indego TherapyEkso Bionics, Inc.PHL2018-08-27
B1431200000EksoEkso Bionics, Inc.PHL2016-09-23
M704501100000IndegoEkso Bionics, Inc.PHL2016-09-15
00861803000303ReWalk(TM) Personal 6.0LIFEWARD LTDPHL2016-09-08
00861803000310ReWalk(TM) PersonalLIFEWARD LTDPHL2016-09-08
00861803000327ReWalk(TM) RehabilitaitonLIFEWARD LTDPHL2016-09-08