FDA.reportPublic FDA data

ReWalk(TM) Personal 6.0

Primary DI
00861803000303
Brand
ReWalk(TM) Personal 6.0
Company
LIFEWARD LTD
Model
50-20-0004
Device description
Powered Exoskeleton - community use
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K160987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160987000ReWalk(TM)Rewalk Robotics, Inc.2016-07-22PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861803000303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861803000303008618030003038618030003030861803000303

GMDN Terms#

Term, Definition table
TermDefinition
Programmable ambulation exoskeleton, home-useA battery-powered, pre-programmed, lower-limb orthosis system intended to enable a patient with a walking disability resulting from spinal cord injury to perform routine ambulatory functions (e.g., stand, walk, ascend and descend stairs); it may also be used to help promote intrinsic motor function. It is typically strapped to the patient over clothing and includes an exoskeleton structure made of metal, with electric motors, mechanical actuators and sensors, an on-board computer, and controls. It is intended for single-patient use, typically outside of a controlled setting following completion of training under professional supervision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (508) 251-1154contact@rewalk.com

Regulatory Flags#

DUNS number
533320867
Device count
1
Serial number
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
00860001744507ReStore50-40-00012019-10-16
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
00860001744507ReStoreLIFEWARD LTDPHL2019-10-16
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
00861803000310ReWalk(TM) PersonalLIFEWARD LTDPHL2016-09-08
00861803000327ReWalk(TM) RehabilitaitonLIFEWARD LTDPHL2016-09-08