ECG app - India CDSCO Medical Device Registration

ECG app is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000754_4331079c3b163712082524bd0d5b2c3e_f8a51c14248fe1efdd5c881c20621640. 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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CDSCO Registered

Class Class B

ECG app

UID: IMP/MD/2022/000754_4331079c3b163712082524bd0d5b2c3e_f8a51c14248fe1efdd5c881c20621640

Brand Name

Atrial Fibrillation History Feature

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (Atrial Fibrillation History Feature) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (Atrial Fibrillation History Feature) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (Atrial Fibrillation History Feature) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old