actiTENS Android app

Organization name

SUBLIMED

SRN

FR-MF-000007546

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW030

  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.

Primary placement in France; available across 3 countries total.

Trade name

actiTENS Android app

UDI-DI code

B786SBM2AA1000

Basic UDI-DI

3770018808SBMTENSAPPNU

Reference / catalog number

SBM2AA100

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

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