THERA-Trainer lyra

GUDID 04041925002775

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.

medica - Medizintechnik GmbH

Treadmill/elliptical gait rehabilitation system

• Primary Device ID: 04041925002775
• NIH Device Record Key: d398ec7d-9b58-4467-bece-c657d7c50de8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERA-Trainer lyra
• Version Model Number: 01.XX.XX
• Company DUNS: 328011325
• Company Name: medica - Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041925002775 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

Devices Manufactured by medica - Medizintechnik GmbH

• 04041925006117 - PHS - XS: 2024-11-22 The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e
• 04041925006124 - PHS - S: 2024-11-22 The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e
• 04041925006131 - PHS - M: 2024-11-22 The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e
• 04041925006148 - PHS - L: 2024-11-22 The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e
• 04041925006155 - PHS - XL: 2024-11-22 The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e
• 04041925005981 - THERA-Trainer toro: 2024-08-27 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
• 04041925006186 - OmniCycle Connect: 2023-11-23 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
• 04041925002706 - THERA-Trainer tigo: 2023-10-31 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr