# K083630: Clue Medical and Clue Medical Basic

- Pathway: 510(k) (Special)
- Applicant: Telovital GmbH Telemedizin
- Decided: Apr 23, 2009 after 136 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895520 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082013: Clue Medical and Clue Medical Basic, Telovital GmbH Telemedizin (2008) Summary page 1.

## Indications for use
The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

Source page: https://510kreport.com/device/K083630
Methodology: https://510kreport.com/methodology