Eu Mdr Eu Md Class 2a On The Market 🇫🇷 France

actiTENS Android app

SUBLIMED · 🇫🇷 France
Devices (same UDI-DI)
6
Certificates
0
Countries
3
Notified Bodies
0

Basic Information

Primary DI
B786SBM2AA1000
Basic UDI-DI Code
3770018808SBMTENSAPPNU
Reference
SBM2AA100
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
SUBLIMED

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.

CND Nomenclature Codes

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

Available In Countries

🇩🇰 Denmark 🇫🇷 France 🇵🇱 Poland

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