AccessGUDID - DEVICE: THERA-Trainer lyra (04041925002775)

GUDID

Device Identifier (DI) Information

Brand Name: THERA-Trainer lyra
Version or Model: 01.XX.XX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: medica - Medizintechnik GmbH

Primary DI Number: 04041925002775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328011325 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47516	Treadmill/elliptical gait rehabilitation system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d398ec7d-9b58-4467-bece-c657d7c50de8
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023