← Back to catalogue

Omego

FDA UDIEUDAMED

Class I (US FDA UDI)

by tyromotion GmbH

Identity

Trade Name
OMEGO FDA UDI
Generic Name
Treadmill/elliptical gait rehabilitation system FDA UDI
Device Name
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders. FDA UDI
Model / Reference
1 FDA UDI
Description
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders. FDA UDI

Identifiers

Primary DI / UDI-DI
09120077180083 FDA UDI
FDA Product Code
BXB FDA UDI
GMDN Term
Treadmill/elliptical gait rehabilitation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5380 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

Omego by tyromotion GmbH — Class I — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
tyromotion GmbH

Sources (2)

  • FDA UDI 42550658-827b-4fbe-a815-6ee3d7b581ab 33 fields · synced Jun 17, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026