FOOTLOGICS SENSI INSOLE M

Organization name

Footlogics Europe B.V.

SRN

NL-MF-000043504

Manufacturer status

Active

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

• CW011

  Do not use this product in cases of acute pain without prior consultation with a healthcare professional. Adaptation to the insole may require a gradual adjustment period; it is recommended to begin with short durations and progressively increase usage to allow the body to adapt.V

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Trade name

FOOTLOGICS SENSI INSOLE M

UDI-DI code

08721161974505

Basic UDI-DI

8721161974FTLSSENSI6A

Reference / catalog number

1053APS M

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

2

Additional product description

Footlogics Sensi is a full-length insole packaged in transparent bag and designed to relieve pressure and friction on very sensitive feet. The top layer is made of Plastazote, a type of memory foam that moulds to your feet and slightly cushions them during use. This provides full support, wearing comfort, and optimal pressure distribution, creating a slight ‘floating sensation. Plastazote is recommended worldwide for diabetic feet and arthritis.

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.

• Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)