enlivio - room4 WebApp

Organization name

room4 Softwareentwicklung GmbH

SRN

AT-MF-000004591

Manufacturer status

Active

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• CW010

  enlivio enables therapists and physicians to provide teletherapeutic care to their patients and offer personalized exercise therapy at home. The enlivio software itself does not make any medical or therapeutic decisions. All medical or therapeutic decisions, as well as the decision to use enlivio for teletherapeutic care are made by the medical specialist, called “therapist” in the following (such as physiotherapists / physician / other occupational therapists in the field of medical-technical services). Important: The use of enlivio cannot replace a visit to a doctor or therapist. Patients with the following characteristics can be treated with enlivio: General: patients must be over 18 years of age. Medical Requirements: The use of enlivio is only suitable for patients who are eligible for medical exercise therapy. The decision for teletherapeutic care of patients is always up to the therapist. Enlivio is certified as a medical product for a) orthopedics and traumatology, b) neurology and c) internal medicine. It is important to note that for corresponding contraindications the use of enlivio is not permitted. Technical requirements: Patients must be in possession of an internet-enabled smartphone or tablet and be able to use it independently. Only devices with an Android operating system with version 5.0 or higher, or with an iOS operating system with version 12.0 or higher are supported. Regular updates of the software are mandatory in order to enable secure teletherapeutic training.

Primary placement in Austria; available across 1 country total.

Placed on the market in Austria; per-country availability dates not published.

Trade name

not provided

UDI-DI code

09120143773027

Basic UDI-DI

912014377ENLIVIOBASEX2

Reference / catalog number

enlivio - room4 WebApp

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12069092VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification