FDA.reportPublic FDA data

Medical HAL Lumbar Type

Primary DI
04560340091824
Brand
Medical HAL Lumbar Type
Company
CYBERDYNE, INC.
Model
HAL-MB04-SMMUS
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560340091824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560340091824045603400918244560340091824

GMDN Terms#

Term, Definition table
TermDefinition
Neuro-controlled joint movement exoskeletonAn electrically-powered, bionic, orthosis system designed to assist a patient with a limb joint movement 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. The system includes an exoskeleton structure made of metal with electric motors and mechanical actuators; it is typically strapped to a limb around a joint (e.g., ankle, knee, shoulder) over clothing and may be used in a pre-programmed configuration. 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
Premarket exempt
true
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
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
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
G345SL2000CIONICCionic, Inc.HCC2026-06-04
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
00816271020902UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020919UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020926UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020933UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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