FDA.reportPublic FDA data

Medical HAL Lower Limb Type

Primary DI
04560340091435
Brand
Medical HAL Lower Limb Type
Company
CYBERDYNE, INC.
Model
HAL-ML07-D2NUS
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
PHLPowered Exoskeleton

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
PHLPowered ExoskeletonPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233695000Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.2024-05-07PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560340091435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560340091435045603400914354560340091435

GMDN Terms#

Term, Definition table
TermDefinition
Neuro-controlled ambulation exoskeletonA battery-powered, bionic, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. It is intended to improve gait after use and may also be used in a pre-programmed configuration. The system includes an exoskeleton structure made of metal with electric motors and mechanical actuators; 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).

Regulatory Flags#

DUNS number
714480766
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560340091749Medical HAL Lumbar TypeHAL-MB04-S22US2026-04-22
04560340091756Medical HAL Lumbar TypeHAL-MB04-S2SUS2026-04-22
04560340091763Medical HAL Lumbar TypeHAL-MB04-S2MUS2026-04-22
04560340091770Medical HAL Lumbar TypeHAL-MB04-SS2US2026-04-22
04560340091787Medical HAL Lumbar TypeHAL-MB04-SSSUS2026-04-22
04560340091794Medical HAL Lumbar TypeHAL-MB04-SSMUS2026-04-22
04560340091800Medical HAL Lumbar TypeHAL-MB04-SM2US2026-04-22
04560340091817Medical HAL Lumbar TypeHAL-MB04-SMSUS2026-04-22
04560340091824Medical HAL Lumbar TypeHAL-MB04-SMMUS2026-04-22
04560340090940HAL for Medical UseHAL-ML05-DSMUS2019-02-01
04560340090957HAL for Medical UseHAL-ML05-DMMUS2019-02-01
04560340090964HAL for Medical UseHAL-ML05-DLMUS2019-02-01
04560340090971HAL for Medical UseHAL-ML05-DXMUS2019-02-01
04560340091060HAL for Medical UseHAL-ML05-DSWUS2019-02-01
04560340091077HAL for Medical UseHAL-ML05-DMWUS2019-02-01
04560340091084HAL for Medical UseHAL-ML05-DLWUS2019-02-01
04560340091091HAL for Medical UseHAL-ML05-DXWUS2019-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665965000167Atalante XWANDERCRAFTPHL2026-05-13
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
06970670070334XFTShenzhen XFT Medical LimitedHCC2026-04-14
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020896UltiumNoraxon U.S.A., Inc.HCC2026-03-30