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Lexo

FDA UDIEUDAMED

Class II (US FDA UDI)

by tyromotion GmbH

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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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