FDA.reportPublic FDA data

Armeo

Primary DI
07640174660285
Brand
Armeo
Company
HOCOMA AG
Model
ArmeoSenso
Published
2018-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640174660285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640174660285076401746602857640174660285

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used to detect and display a patient’s physical exercise/movements/actions, and sometimes provide performance feedback, while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology ambulatory recorder, as part of physical assessment/rehabilitation. It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing patient performance data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
487876203
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640174660353ArmeoSpring Pro619582023-10-11
07640174660377ManovoSpring295682023-10-11
07640174660391ArmeoSupport Harness626442023-10-11
07640174660452LokomatPro 6.3 PE630572023-03-23
07640174660469LokomatPro 6.3 Kombi Motivation630582023-03-23
07640174660476LokomatPro 6.3 AD Motivation630592023-03-23
07640174660483LokomatPro 6.3 PE Motivation630602023-03-23
07640174660490LokomatNanos 1.3630612023-03-23
07640174660407LokomatPro 6.3 FD Kombi630522023-03-22
07640174660414LokomatPro 6.3 FD AD630532023-03-22
07640174660421LokomatPro 6.3 FD PE630542023-03-22
07640174660438LokomatPro 6.3 Kombi630552023-03-22
07640174660445LokomatPro 6.3 AD630562023-03-22
07629999033894ErigoPro296732016-03-11
07640174660001ArmeoSpring264052016-08-22
07640174660018ArmeoSpring Pediatric273262016-08-22
07640174660032ErigoBasic295642016-08-22
07640174660056ErigoBasic296722016-08-22
07640174660063LokomatPro300002016-08-22
07640174660070LokomatPro300012016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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