actiTENS iOS app

Dénomination commerciale

actiTENS iOS app

B786SBM2AA2000

3770018808SBMTENSAPPNU

Numéro de référence/catalogue

SBM2AA200

HIBCC

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The actiTENS/actiTENS mini is a connected medical device for transcutaneous electrical neurostimulation for nerve and muscle stimulation. It is indicated for relief of pain and neuromuscular rehabilitation and intended for persons over 6 years of age with unimpaired intellectual abilities. The actiTENS/actiTENS mini is fixed directly on to the body using a fastening accessory. It adapts to the shape of your body with its flexible design. The device 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/actiTENS mini, we recommend that a healthcare professional instruct you how to correctly position the electrodes and to select an appropriate stimulation program for your specific needs.

URL des informations complémentaires

https://subli-med.com/wp-content/uploads/2017/11/Notice.pdf%20%20&%20%20https://subli-med.com/wp-content/uploads/2017/11/Notice_en_gb.pdf

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• Consulter un professionnel de la santé avant toute utilisation

  The actiTENS should not be used on the following patients without medical advice: - Patients with pacemakers, implantable cardioverter defibrillators, or other similar electronic implantable devices. - Patients at risk of heart problems. - Patients with epilepsy. - Patients with decreased or impaired sensation or sensibility on the area to be treated, for example patients suffering from allodynia (pain triggered by a normally painless stimulus). - actiTENS should not be used on pregnant women without medical advice. The electrodes must not be placed on the abdomen of a pregnant woman. Failure to respect these contra-indications may have serious consequences and be harmful to the patient.