# K083229: E.S Teck ( Electro Sensor Teck)

- Pathway: 510(k) (Traditional)
- Applicant: Ld Technology, LLC
- Decided: Feb 23, 2009 after 112 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050620: Readmyheart, Model RMH3.0, Dailycare Biomedical, Inc. (2005) Summary page 2.
- K072825: Fingertip Pulse Oximeter, Model MD300I, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 2.
- K023238: Mcpulse, Meridian Co., Ltd. (2003) Summary page 2.

## Most influential descendants
- K102442: E.S.O. (Electro Sensor Oxi) (2010), 4 descendants of its own
- K160956: LD-Oxi system (2016), 2 descendants of its own
- K200141: Oxi-W System (2020), 1 descendant of its own
- K253306: BioTracker 2.0 (2026), 0 descendants of its own
- K130056: Patient Monitor (2013), 0 descendants of its own

## Indications for use
Each module has specific feature and intended use 1. Pulse Oximeter: * To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. * To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. 2. Heart rate variability (HRV) * To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the ES Teck software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (2 minutes) The device is intended use in licensed practitioner's office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by licensed practitioner.

Source page: https://510kreport.com/device/K083229
Methodology: https://510kreport.com/methodology