Atalante X

Primary DI
03665965000129
Brand
Atalante X
Company
WANDERCRAFT
Model
ATA-002-EN US
Device description
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
Published
2023-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K221859000
K232077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221859000AtalanteWandercraft SAS2022-12-29PHL
K232077000Atalante XWandercraft SAS2023-12-13PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665965000129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665965000129036659650001293665965000129

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.

Regulatory Flags#

DUNS number
264523488
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665965000204EveEXTRA LARGE LEGS - STANDARD VEST - US2026-09-25
03665965000211EveLARGE LEGS - STANDARD VEST - US2026-09-25
03665965000228EveMEDIUM LEGS - STANDARD VEST - US2026-09-25
03665965000235EveSMALL LEGS - STANDARD VEST - US2026-09-25
03665965000242EveEve DEMO - STANDARD VEST - WW2026-09-25
03665965000167Atalante XATA-2.5.1-EN US2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665965000204EveWANDERCRAFTPHL2026-09-25
03665965000211EveWANDERCRAFTPHL2026-09-25
03665965000228EveWANDERCRAFTPHL2026-09-25
03665965000235EveWANDERCRAFTPHL2026-09-25
03665965000242EveWANDERCRAFTPHL2026-09-25
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
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