Identity
- Trade Name
- LEXO FDA UDI
- Generic Name
- Treadmill/elliptical gait rehabilitation system FDA UDI
- Device Name
- The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk. FDA UDI
- Model / Reference
- R1 FDA UDI
- Description
- The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120077180076 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
Yes
FDA UDI
Category: Treadmill/elliptical gait rehabilitation system
Lexo by tyromotion GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Treadmill/elliptical gait rehabilitation system.
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- OMEGO — tyromotion GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- tyromotion GmbH
Sources (2)
- FDA UDI dc239adf-c5c3-453e-9be1-6afbc1f332b5 33 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026