# K101569: V-Trust Model TD-2202 Portable Ecg Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Mar 1, 2011 after 270 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950944 (1996). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071085: E3-80 Portable Ecg Recorder & Analyzer, Micro-Star International Co., Ltd. (2007) Summary page 2.
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 2.

## Most influential descendants
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own
- K131572: Micro Ambulatory Ecg Recorder (2013), 0 descendants of its own

## Indications for use
The V-TRUST TD-2202 portable EGG recorder is intended for recording and displaying EGG data of adult patients who are concerned about their heart rhythm. A patient can either equip a five lead-wires EGG cable to take a long term monitoring; or choose to use event reading option when feeling any heart condition occur. This recorder allows the patient to record their EGG data in SD memory card and playback the data for analysis by a physician or those knowledgeable about EGG morphology, rhythm, and arrhythmia. The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

Source page: https://510kreport.com/device/K101569
Methodology: https://510kreport.com/methodology