Irregular Rhythm Notification Feature
- UID
- IMP/MD/2022/000754_2ae4c1abcd87e3400ffd1f172863b0a4_03181e068806940e9b3323e36449497d
- Device class
- Class B
- Brand name
- Atrial Fibrillation History Feature
- License holder
- M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.
- Approving authority
- CDSCO
- Product information
- The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (Atrial Fibrillation History Feature) and provides a notification to the user. The feature is intended for over-the-counter (Atrial Fibrillation History Feature) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib
Irregular Rhythm Notification Feature is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000754_2ae4c1abcd87e3400ffd1f172863b0a4_03181e068806940e9b3323e36449497d. This device is marketed under the brand name Atrial Fibrillation History Feature. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class B. The approving authority is CDSCO.
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