Documentation — JawSpace – Award-winning TMD & TMJ self-care

Regulatory & Intended Use Disclaimer

JawSpace® is available in two versions.

The JawSpace lifestyle and wellness version is intended for general educational purposes only and to support awareness and self-management of symptoms commonly associated with Temporomandibular Disorders (TMD). This version is not intended to diagnose, treat, cure, or prevent any medical conditions. Some features available in the medical version of JawSpace are not accessible in the lifestyle and wellness version.

The JawSpace medical version is registered as a Class I Software as a Medical Device (SaMD) in Australia and the United Kingdom, in accordance with applicable regulatory requirements. It is intended to support people who have received a diagnosis of TMD from a qualified healthcare professional, through evidence-based self-management guidance and symptom support. It is designed to complement – not replace – care provided by a qualified healthcare professional.

JawSpace does not provide medical diagnosis or clinical decision-making. Users should not change or discontinue prescribed treatments or medications without consulting a qualified healthcare professional.

Users should always read and follow the Instructions for Use (IFU) provided for the version of JawSpace they are using.

Regulatory submissions for additional regions, including the United States and Europe, are underway.