INKA v2.1.x

Organization name

NEXTEC medical GmbH

SRN

DE-MF-000005572

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

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

Trade name

not provided

UDI-DI code

04260705080127

Basic UDI-DI

426070508MD-INKADiGA22TC

Reference / catalog number

INKA v2.1.x

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

INKA is a digital application to support the treatment of patients with overactive bladder (OAB) with or without incontinence or combined with stress incontinence. INKA is used for: - monitoring the progress of therapy - alleviation of symptoms - behavior detection and change - and increasing the quality of life. INKA provides features for motivating patients as well as various functions for personalized therapy support and monitoring, such as: - pelvic floor training - educational content about the disease, causes, and behavior - drinking recommendations - bladder training or distraction exercises. The minimum age for using the app is 18 years. Patients should have experience with the use of a smartphone.

Additional information URL

https://www.meine-inka.de/Meine_Inka_Gebrauchsanweisung_A4_Web.pdf

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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