602803

Organization name

Focal Meditech BV

SRN

NL-MF-000000536

Manufacturer status

Active

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• 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

08719327649367

Basic UDI-DI

87193276493FOCSL1QB

Reference / catalog number

602803

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

The dynamic arm support Sling is a set of axes equipped with a string. The string connects an arm-fitting (Human Interface) with a counterweight. The Sling will always be attached to the 'fixed' world (chair, wheelchair or frame). The forearm rests in the Human Interface, the Sling can now largely bear the weight of the arm and relieve the pectoral girdle. The counterweight will allow every movement of the arm and hand against gravity. Dynamic arm supports are mainly used by people with limited strength in the pectoral girdle or arm due to neurological or orthopaedic state of these areas. By using their own residual capabilities, these people can move their hands to where it is useful. Reaching, grasping, moving things and all kinds of everyday activities are now possible. The Sling works in both the horizontal and the vertical way and requires no electrical power. A typical feature of the Sling is that the whole suspension approaches the user’s arm from above. In this way, unlike other types of arm support, there are no parts under the arm that may occupy space. Arm support systems of this type are very suitable in case the device could come into conflict with objects such as the working table, joystick, armrest or keyboard. As a result, the Sling is used by people with their own capabilities and desires.

Additional information URL

https://www.focalmeditech.nl/sling/

Clinical sizes

No clinical sizes registered for this device.

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

• Y241899ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER