TCH-201
Medical
Only for iPhone
Free · Designed for iPhone. Not verified for macOS.
iPhone
An application and device for the management of TMD related symptoms. The Nerivio Infinity device is an investigational device for the management of TMD related symptoms and is not yet available on the market. This application is intended for use only as a part of the TCH-201 clinical study and under the advisement and supervision of the study staff.
Application shall be used only by TCH-201 clinical study participants in the US after passing the pre-clinical screening by selected hospitals/clinics and in conjunction with the medical device that will be distributed by the clinic.
Disclaimer – this is an application for a TCH-201 clinical trial, please seek a doctor’s advice in addition to using this app and before making any medical decisions.
Ratings & Reviews
- This app hasn’t received enough ratings or reviews to display an overview.
The developer, Theranica, 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:
- Health & Fitness
- Contact Info
- Other Data
Data Not Linked to You
The following data may be collected but it is not linked to your identity:
- Location
- Diagnostics
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Seller
- Theranica Ltd.
- Size
- 54.9 MB
- Category
- Medical
- Compatibility
Requires iOS 16.0 or later.
- iPhone
Requires iOS 16.0 or later. - Mac
Requires macOS 13.0 or later and a Mac with Apple M1 chip or later. - Apple Vision
Requires visionOS 1.0 or later.
- iPhone
- Languages
- English
- Age Rating
9+
- 9+
- Medical Device
Yes
- Theranica 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
- 10060818
- Address
- 4 Haalon
Kfar Netter
Israel - Phone Number
- +972 54-440-7876
- irisr@theranica.com
- Use Statement
- An application and device for the management of TMD related symptoms. The Nerivio Infinity device is an investigational device for the management of TMD related symptoms and is not yet available on the market. This application is intended for use only as a part of the TCH-201 clinical study and under the advisement and supervision of the study staff.
Application shall be used only by TCH-201 clinical study participants in the US after passing the pre-clinical screening by selected hospitals/clinics and in conjunction with the medical device that will be distributed by the clinic.
Disclaimer – this is an application for a TCH-201 clinical trial, please seek a doctor’s advice in addition to using this app and before making any medical decisions. - Safety Information
- This is the updated safety information:
Contraindications
The device should not be used by people with uncontrolled epilepsy.
The device should not be used by people with active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device. Such use could cause electric shock, electrical interference or serious injuries or medical conditions.
Warnings:
Do not attempt to perform any procedure before carefully reading all the instructions.
Do not use the device on the heart, chest, neck, head or any other body location other than the upper arm, because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
Do not use the device over skin conditions, such as open wounds or rashes, or over swollen, red, infected or inflamed areas or skin eruptions or fragile skin on your upper arm at the treatment location.
Do not share the device with other people. The device is intended to be used by a single person to avoid skin disease or any transmissible disease.
Do not disassemble, immerse in water, crush, expose to a violent vibration, incinerate, over-charge, overheat or short-circuit the battery or the device. This could cause a fire, injury, burns, or other hazards.
Use only class II, IEC 60601-1 certificated AC wall adapter/charger with two means of operator protection to charge the device (as provided to you)
Do not place the device on a body without attaching electrodes and do not touch the device contacts when it is operational.
Do not charge the device when placed on the body or during treatment. - Instructions for Use
- Visit the developer site
- Copyright
- © Theranica Bio-Electronics LTD