# K112573: Ezsleep Sleep Quality Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Platinum Team Co., Ltd.
- Decided: Mar 22, 2012 after 198 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950944 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.
- K001025: Lifecard CF Compact Recorder, Reynolds Medical, Ltd. (2000) Summary page 1.

## Indications for use
The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis. The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.

Source page: https://510kreport.com/device/K112573
Methodology: https://510kreport.com/methodology