SBM7AA100

Nom de l'organisation

SUBLIMED

SRN

FR-MF-000007546

Statut du fabricant

Actif

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

• CW030

  Consult healthcare professional before use-(Description)The actiTENS mini 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 mini 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

Marché principal en France ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

03770018808260

Basic UDI-DI

3770018808SBMTENSAPPNU

Numéro de référence/catalogue

SBM7AA100

Entité d'attribution

GS1

Catégorie de risque

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 mini 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 mini 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 mini 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 mini, 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.

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.

• Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

• Numéro de lot
• Date d'expiration
• Date de fabrication
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• Identification du logiciel