Eu Mdr
Eu Md Class 2a
On The Market
🇫🇮 Finland
VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 06432100120120
- Basic UDI-DI Code
- 643210VRP00138
- Reference
- ROHKEA™ VR Therapy
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Orion Corporation
Additional Description
The intended purpose of the Rohkea™ VR Therapy is to provide an automated intervention based on cognitive behavioral therapy intended to help the subject overcome fear of movement. The device is intended for in-home use and to be assigned by health care professional. The product is intended to be used by competent adult (age ≥ 18 years) patients with fear of movement caused by chronic musculoskeletal pain.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12069092 | VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
🇮🇪 Ireland
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