Document ID: chunk:federal_register_of_legislation:F2024C00750:reg:14b
Version: federal_register_of_legislation:F2024C00750
Segment Type: reg
Provision Reference: reg 14B
Character Range: 10169–10954

14B              software, or a combination of software and non-invasive hardware, that is:
                 (a) intended by its manufacturer to be used by a consumer to promote or facilitate general health or wellness by measuring or monitoring (through non-invasive means) a physical parameter, such as movement, sleep, heart rate, heart rhythm, temperature, blood pressure or oxygen saturation; and
                 (b) not intended by its manufacturer to be used:
                        (i) in clinical practice; or
                        (ii) for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a serious disease or a serious condition, ailment or defect