FDA.reportPublic FDA data

Armeo

Primary DI
07640174660186
Brand
Armeo
Company
HOCOMA AG
Model
Power
Catalog number
30805
Published
2016-08-22
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
IKKSystem, Isokinetic Testing And Evaluation
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640174660186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640174660186076401746601867640174660186

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
Manufacturing date on label
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
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
00860010525609Proprio SystemsPerry Dynamics, Inc.IKK2026-07-29
00860010525616Proprio SystemsPerry Dynamics, Inc.IKK2026-07-28
06978410840063FourierFourier Intelligence Inc.IKK2026-07-16
06978410840070FourierFourier Intelligence Inc.IKK2026-07-16
06978410840087FourierFourier Intelligence Inc.IKK2026-07-16
06975343590362Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
06975343590379Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14