FDA.reportPublic FDA data

Armeo

Primary DI
07640174660391
Brand
Armeo
Company
HOCOMA AG
Model
Support Harness
Catalog number
62644
Published
2023-10-11
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640174660391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640174660391076401746603917640174660391

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
487876203
Device count
1
Premarket exempt
true
Lot or batch
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
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
07640174660087LokomatPro300022016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03