510(k) · Cleared
ClearedeMotion Faros 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 Mar 29, 2015 as substantially equivalent to K131699 (Mega Electronics, Ltd., 2013) after a 158-day review. Its family tree reaches back 6 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 29, 2015
- Review
- 158 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963725 (1997). 16 ancestors in all, the oldest K960499 (1996). 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 2 generations backK083535 Heartrak Smart EcatUniversal Medical, Inc. · 2008
- 1 generation backK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- This deviceK143032 eMotion Faros ECG MobileMega Electronics, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK232053 SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161431SimplECGNanowear, Inc. · 2016 · cites it directly5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 2 generations on3descendants
- K212160SimpleSENSE PlatformNanowear, Inc. · 2021 · 3 generations on1descendant
- K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025 · 3 generations on0descendants
- K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −2 | K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | 2008 | — |
| −1 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| 0 (this device) | K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | 2015 | — |
| +1 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +2 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +3 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +3 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
| +4 | K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K131699 | Emotion Ecg MobileSummary page 4…Class IIa Medical Device Directive: 93/42EEC as a amended by 2007/47/EC 4. Substantial Equivalence, Predicate Device eMotion ECG Mobile, 510(k) Number: K131699 Confidential Page 1 of (4) 007 510k Summary re… | 2013 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161431 | SimplECG | 2016 | 5 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K161431 (Nanowear, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K131699.
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. 2015, 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 Faros ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. The eMotion Faros 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…
Read the full statement (123 words)
The eMotion Faros ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion Faros 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.
Indicated for adult patients who require clinical or non-clinical ECG monitoring in healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment.
The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143032: eMotion Faros ECG Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143032
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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