608385

Organization name

Focal Meditech BV

SRN

NL-MF-000000536

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 5 countries total.

Trade name

not provided

UDI-DI code

08721398039008

Basic UDI-DI

8720299756FOCUAMMQ

Reference / catalog number

608385

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

A Universal Actuator Module converts electrical energy into translational or rotary motion. When the device is built on the wheelchair by Focal Meditech, this energy usually comes from the “Fomoco DC-5/2”. Settings such as speed (volt), maximum torque (Ampere) used by the motor, and the mapping of the user input are configured within this controller. If a universal actuator module is controlled by a third-party controller there should be taken care of those settings.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y240999CONTROL DEVICES AND SYSTEMS - OTHER