Medical Device Disclaimer
Important information about the nature of this website and the SCASE Smart Health Monitor.
This website is promotional information only
This website provides promotional and product information about the SCASE Smart Health Monitor and the activities of FeelWell Health Ltd as the UK exclusive distribution partner. It is not medical advice. Nothing on this website should be interpreted as a clinical recommendation, diagnosis, treatment plan or substitute for professional medical guidance.
Seek advice from a healthcare professional
Users should seek advice from an appropriate healthcare professional — such as their GP, nurse or pharmacist — for individual health concerns. If you are concerned about any health measurement or symptom, please contact a qualified healthcare professional promptly. In an emergency, call 999.
SCASE is a regulated medical device
The SCASE Smart Health Monitor (model SCaseD01) is a CE-marked medical device under the EU Medical Device Regulation (MDR), Class IIb. It is manufactured by S-Case s.r.o. of Slovakia. FeelWell Health Ltd is the authorised exclusive UK distribution partner.
The device is intended to be used in accordance with the manufacturer's instructions for use. FeelWell Health Ltd makes no clinical claims beyond those supported by the device's regulatory documentation and the manufacturer's intended purpose.
No diagnostic or treatment claims
FeelWell Health Ltd does not make any claims that the SCASE Smart Health Monitor:
- Diagnoses any medical condition
- Treats, manages or cures any medical condition
- Replaces professional clinical assessment
- Is superior to any other device or monitoring method
- Produces clinically actionable results without professional interpretation
The measurements captured by SCASE are intended to support structured data collection and monitoring. Any clinical interpretation of results should be performed by a qualified healthcare professional.
ECG capability
ECG capability is available through a compatible connected external device. ECG is not a built-in function of the main SCASE unit. Any ECG data obtained through connected external devices should be interpreted by a qualified clinical professional.
Home users
The SCASE home-use edition is intended for personal health monitoring. Home users should not rely solely on SCASE readings to make clinical decisions about their health. Any readings of concern should be discussed with a GP or other appropriate healthcare professional.
UK regulatory status
FeelWell Health Ltd works with the manufacturer and the appointed UK Responsible Person to support compliance with applicable UK medical device regulations. For queries regarding the regulatory status of the SCASE device in the UK, please contact us at info@feelwellhealth.co.uk.
Limitation of liability
To the fullest extent permitted by applicable law, FeelWell Health Ltd accepts no liability for any loss or damage arising from reliance on the information contained on this website, or from use of the SCASE Smart Health Monitor otherwise than in accordance with its instructions for use and applicable regulatory requirements.
Contact
If you have any questions about this disclaimer, the SCASE device or its regulatory status, please contact FeelWell Health Ltd at info@feelwellhealth.co.uk.