FDA.reportPublic FDA data

THERA-Trainer lyra

Primary DI
04041925002775
Brand
THERA-Trainer lyra
Company
medica - Medizintechnik GmbH
Model
01.XX.XX
Device description
The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
Published
2023-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04041925002775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041925002775040419250027754041925002775

GMDN Terms#

Term, Definition table
TermDefinition
Treadmill/elliptical gait rehabilitation systemAn assembly of electrically-powered devices designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. It primarily consists of a speed-regulated treadmill or elliptical to facilitate gait; an overhead patient support assembly with pulleys, harness, and straps to unload patient weight; a robotic orthosis system attached to the patient's legs individually, or in the form of pedals, to guide leg movements; side-mounted rails for patient support; an operator control unit to regulate speed/elevation and display related data; and sometimes patient incentive features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328011325
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041925006339PHS - XSGBS 01.YY.ZZA008-6852026-05-13
04041925006346PHS - SGBS 01.YY.ZZA008-6862026-05-13
04041925006353PHS - MGBS 01.YY.ZZA008-6872026-05-13
04041925006360PHS - LGBS 01.YY.ZZA008-6882026-05-13
04041925006377PHS - XLGBS 01.YY.ZZA008-6892026-05-13
04041925006117PHS - XSGBS 01.YY.ZZA008-6852024-11-14
04041925006124PHS - SGBS 01.YY.ZZA008-6862024-11-14
04041925006131PHS - MGBS 01.YY.ZZA008-6872024-11-14
04041925006148PHS - LGBS 01.YY.ZZA008-6882024-11-14
04041925006155PHS - XLGBS 01.YY.ZZA008-6892024-11-14
04041925006230THERA-Trainer bemo02.YY.ZZA006-8772026-03-16
04041925006247THERA-Trainer bemo02.YY.ZZA006-8782026-03-16
04041925002812THERA-Trainer bemo01.XX.XX2023-10-23
04041925006254THERA-Trainer toro01.05.ZZ2025-12-16
04041925006261THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006278THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006285THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006308OmniCycle® Revo 01.05.ZZ2025-12-16
04041925006315OmniCycle® Revo01.05.ZZ2025-12-16
04041925006193THERA-Trainer toro01.YY.XX2025-09-04

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