actiTENS
Medical
Only for iPhone
Free
iPhone
actiTENS is a transcutaneous electrical nerve stimulator (TENS), operated via a mobile application and based on the TENS principle to relieve pain in adults.
Back to an Active Life
Specifically designed to offer an ergonomic and discreet solution, the device adapts to various body types and different areas of the body and can be worn under clothing. actiTENS comes with a wide range of accessories, including specialized electrodes and various fastening supports, all designed to optimize pain management during daily activities.
One app, two functions
The actiTENS app is a personalised treatment tool that allows users to both control the device via the integrated remote control function and access the list of programmes. The app also serves as a therapy monitoring tool through the “My Health” menu, and supports mobility tracking thanks to the built-in pedometer.
Patient Account Creation and Cloud Security
For an even more personalized experience, actiTENS offers the option to create a patient account. This account not only saves preferences and tracking data in a secure cloud. Creating an account ensures information portability, regardless of the smartphone used. This functionality ensures continuity in treatment monitoring, promoting optimal care.
Recommendation from Healthcare Professionals
Despite the customization available through the application, consulting a healthcare professional is recommended. This ensures proper electrode placement and the selection of programmes most suitable for each user's specific situation.
actiTENS represents a innovative and discreet solution for pain management. With the integration of a pedometer and the option to create a patient account, it provides a comprehensive approach to well-being while ensuring the security and continuity of treatment monitoring.
Ratings & Reviews
Minor bug fixes.
The developer, SUBLIMED, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .
Data Linked to You
The following data may be collected and linked to your identity:
- User Content
Data Not Linked to You
The following data may be collected but it is not linked to your identity:
- Identifiers
- Usage Data
- Diagnostics
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Seller
- SUBLIMED
- Size
- 64.8 MB
- Category
- Medical
- Compatibility
Requires iOS 15.0 or later.
- iPhone
Requires iOS 15.0 or later. - iPod touch
Requires iOS 15.0 or later.
- iPhone
- Languages
English and 5 more
- English, Danish, French, German, Italian, Polish
- Age Rating
13+
- 13+
- Infrequent
Medical Treatment information
- Medical Device
Yes
- SUBLIMED indicated this app is a regulated medical device and complies with United States law.
- The information below has not been verified by Apple.
- FDA Owner/Operator Number
- 3015588280
- Address
- 137 Rue Mayoussard
38430 Moirans
France - Phone Number
- +33 6 86 65 59 51
- contact@subli-med.com
- Use Statement
- Over-the-counter use:
actiTENS Mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following
indications:
• Symptomatic relief and management of chronic, intractable pain
• Temporary relief of pain associated with sore and aching muscles due to strain
from exercise or normal household and work activities
• Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13, P15 and P16 correspond to
TENS mode.
Prescription use:
actiTENS Mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following
indications:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Temporary relief of pain associated with sore and aching muscles due to strain
from exercise or normal household and work activities
• Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13, P15 and P16 correspond to
TENS mode.
Electrical Muscle Stimulation (EMS), used for the following indications:
• Temporary relaxation of muscle spasms
• Prevent or retard disuse atrophy
• Increase of local blood flow in the treatment area
• Re-educate muscles
• Maintain or increase the range of motion
• Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode. - Safety Information
- 1. CONTRAINDICATIONS
The actiTENS Mini must NOT be used (is contraindicated) by the following:
• Patients with pacemakers, implantable cardioverter defibrillators, or other
similar active implantable devices.
• Heart-risk patients.
• Patients with epilepsy.
• People with dermatological conditions in the area of the electrode’s
placement.
• Allodynia.
• Allergy to electrodes.
• Pregnant women.
• Children (under 22).
2. RESIDUAL RISKS AND UNDESIRABLE SIDE EFFECTS
• The use of actiTENS Mini can in some cases cause hyperalgesia (abnormally
amplified pain caused by a painful stimulus). It is recommended to stop using
the device and to consult a healthcare professional.
• Use of the actiTENS Mini may in certain cases cause erythema (redness), skin
irritation, inflammation, allergy or burns in the area where the electrodes are
placed or the area where textile accessories are fixed. In case of skin irritation
after a stimulation session, you should stop the treatment temporarily and
consult a healthcare professional.
• If the electrodes start to peel off, this may cause a slight electric shock. Make
sure you change your electrodes regularly to limit peeling off (see section 11).
• Using the actiTENS Mini may cause temporary muscular pain or involuntary
muscular contractions. It is recommended to consult a healthcare professional
before using the device and stop using it if these effects happen.
• Some accessories (cables, AC charger and textile accessories) may present a risk
of strangulation.
3. WARNINGS
• Do not position the electrode and the neurostimulator on the front of the neck
(especially the carotid sinus for patients with a known sensitivity to the carotid
sinus reflex) as this may cause adverse effects on heart rate or blood pressure
or cause severe muscle spasms resulting in airway closure and difficulty
breathing.
• Do not position the electrode on the chest on either side of the heart. Placement
of the electrodes near the thorax can increase the risk of cardiac arrhythmia.
• Do not use the neurostimulator for transcranial stimulation (electrodes on
either side of the head), effects of transcranial stimulation on the brain are
unknown.
• Do not place the electrodes directly over the spinal column.
• Do not place the electrodes on a pathological limb as stimulation should not be
applied over swollen, infected, or inflamed areas or skin eruptions, e.g., active
phlebitis, thrombophlebitis, varicose veins, etc
• Never place the electrodes inside body openings; they are designed solely for
external application. Do not apply stimulation directly to the eyeballs or mouth.
• For hygiene reasons, the electrodes must only be used by a single patient.
• Do not attempt to open or modify the actiTENS Mini - there is a risk of electric
shock.
• Do not use the neurostimulator if the patient is connected to high-frequency
surgical equipment (e.g., electric scalpel). Simultaneous use can cause burns
underneath the electrodes and damage to the neurostimulator.
• Do not use the actiTENS Mini neurostimulator in the immediate vicinity (e.g. 1
m) of shortwave or microwave devices. The output power of the device may be
affected, which may turn into painful reactions.
• Do not use the neurostimulator near electronic surveillance equipment (e.g.
cardiac monitors, ECG, EEG), as there is a risk they may not work properly whilst
the neurostimulator is being used.
• Keep the actiTENS Mini neurostimulator away from water and other liquids.
• Do not use the device in a flammable environment (ex: gas station).
• Do not use the actiTENS Mini device in emergency medical services.
• We recommend not to use the actiTENS Mini neurostimulator while sleeping,
as pain may be felt too late.
• Caution should be taken in the case of patients with psychological disorders or
electrophobia.
• Do not use several stimulators at the same time on the same person.
• The long-term effect of chronic electrical stimulation are unknown.
• Stimulation should not be applied over, or in proximity to, cancerous lesions. - Instructions for Use
- Visit the developer site
- Copyright
- © 2017 - 2023 Sublimed SAS