# K171019: ScioCardio ECG Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Synergen Technology Labs, LLC
- Decided: May 30, 2018 after 420 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K882803 (1988). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150289: Cardioline HD+, Cardioline S.P.A (2015) Summary page 4.
- K112921: Medicalgorithmics Unified Arrhythmia Diagnostic System, Medicalgorithmics S.A. (2012) Summary page 4.

## Indications for use
ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired. ScioCardio ECG transmitter acquires Lead II and Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body. ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device. ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App. ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

Source page: https://510kreport.com/device/K171019
Methodology: https://510kreport.com/methodology