Eu Mdr Eu Md Class 2a On The Market

actiTENS

actiTENS kit : The actiTENS is a connected medical device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities coffret VitaliTENS : VitaliTENS is a medical device for transcutaneous electrical neurostimulation intended to treat chronic pain in adults suffering from knee osteoarthritis

Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
03770018808215
Basic UDI-DI Code
3770018808SBMKitCoffretZH
Reference
SBM1AA008
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The actiTENS is a connected medical device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities. The actiTENS is fixed directly on to the body using a self-adhesive strip or textile accessory. It adapts to the shape of your body with its flexible design. The actiTENS can be used discreetly during your daily activities. It is operated through a smartphone app that allows you to choose from a wide number of stimulation programs and to save all the information recorded from the stimulation treatment sessions. To get the most out of your actiTENS, we recommend that a healthcare professional instruct you how to correctly position the electrodes and to select an appropriate stimulation programme for your specific needs.

Medical Purpose

actiTENS kit : The actiTENS is a connected medical device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities coffret VitaliTENS : VitaliTENS is a medical device for transcutaneous electrical neurostimulation intended to treat chronic pain in adults suffering from knee osteoarthritis

CND Nomenclature Codes

Code Description
Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) [correction as of 2025-01-01]

Related Devices

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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