Basic Information
- Primary DI
- 03770018808154
- Basic UDI-DI Code
- B-03770018808154
- Reference
- SBM1AA100
- Device Types
- None provided
- Regulation
- Eu Mdd
- 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] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 654972 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).