FDA.reportPublic FDA data

HAL for Medical Use

Primary DI
04560340090940
Brand
HAL for Medical Use
Company
CYBERDYNE, INC.
Model
HAL-ML05-DSMUS
Device description
Number of legs: DoubleLeg length: ShortHip width: Medium
Published
2019-02-01
Public version status
Update
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
K171909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171909000HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc.2017-12-17PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560340090940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560340090940045603400909404560340090940

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
714480766
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560340091435Medical HAL Lower Limb TypeHAL-ML07-D2NUS2026-04-22
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
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
G345SL2000CIONICCionic, Inc.HCC2026-06-04
03665965000167Atalante XWANDERCRAFTPHL2026-05-13
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.PHL2026-04-22
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
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