Identity
- Trade Name
- THERA-Trainer lyra FDA UDI
- Generic Name
- Treadmill/elliptical gait rehabilitation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 01.XX.XX FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04041925002775 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Treadmill/elliptical gait rehabilitation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treadmill/elliptical gait rehabilitation system
THERA-Trainer lyra by medica Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treadmill/elliptical gait rehabilitation system.
- LEXO — tyromotion GmbH · Class II
- OMEGO — tyromotion GmbH · Class I
- Morning Walk — CUREXO, Inc. · Class II
- G-EO — Reha Technology AG · Class II
- G-EO System — Reha Technology AG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- medica Medizintechnik GmbH
Sources (1)
- FDA UDI d398ec7d-9b58-4467-bece-c657d7c50de8 33 fields · synced May 30, 2026