510(k) · Cleared
ClearedEmotion Ecg Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mega Electronics, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Nov 26, 2013 as substantially equivalent to K083535 (Universal Medical, Inc., 2008) and 1 other predicate after a 168-day review. Its family tree reaches back 5 generations to 1997. 16 later devices descend from it.
- Decided
- Nov 26, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963725 (1997). 15 ancestors in all, the oldest K960499 (1996). 16 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 2 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 1 generation backK083535 Heartrak Smart EcatUniversal Medical, Inc. · 2008
- This deviceK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK141813 Rhythmstar SystemRhythMedix, LLC · 2014
- Descendant · cites it directly · 6 of its ownK143032 eMotion Faros ECG MobileMega Electronics, Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK183704 RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K141813Rhythmstar SystemRhythMedix, LLC · 2014 · cites it directly8descendants
- K143032eMotion Faros ECG MobileMega Electronics, Ltd. · 2015 · cites it directly6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 2 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 3 generations on3descendants
- K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −2 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −1 | K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | 2008 | — |
| 0 (this device) | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| +1 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
| +1 | K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | 2015 | — |
| +2 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +3 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +2 | K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083535 | Heartrak Smart EcatSummary page 1…DXH Device Class: Class 11 Classification Panel: Cardiovascular S. Predicate Devices Heartrak Smart ECAT, 510(k) Number: K083535 Card Guard PMP4 Medical Web Center, 510(k) Number: K050940 Sect 5 - Page 1 of… | 2008 |
| * | K050940 | PMP4 Medical Web CenterSummary page 1…assification Panel: Cardiovascular S. Predicate Devices Heartrak Smart ECAT, 510(k) Number: K083535 Card Guard PMP4 Medical Web Center, 510(k) Number: K050940 Sect 5 - Page 1 of 1 Mega Electronics LTD Traditional 510(k) Premar… | 2005 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K141813 (RhythMedix, LLC, 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K083535.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation.
Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters.
The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131699: Emotion Ecg Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131699
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026