Smartheart E-486-0
GUDID 07290008960380
The SmartHeart is a portable battery powered, 12-lead ECG and rhythm strip device with Bluetooth connection. SmartHeart acquires ECG data via electrodes on the housing and the electrode belt placed on the chest and electrodes in the left and right armpits and the waist. SmartHeart transmits the data in real-time to a suitable Bluetooth communication device (smartphone or tablet) equipped with a Mobile Application so that it can be forwarded to the remote location equipped by Cardio Medical Center Vision (K003392) or equivalent software for a medical professional review.
SHL TELEMEDICINE INTERNATIONAL LTD.
Electrocardiograph, home-use| Primary Device ID | 07290008960380 |
| NIH Device Record Key | 17bd68dc-940a-449d-8565-10a5cce8eb71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smartheart |
| Version Model Number | 3.3 |
| Catalog Number | E-486-0 |
| Company DUNS | 531817906 |
| Company Name | SHL TELEMEDICINE INTERNATIONAL LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com | |
| Phone | 1-866-745-8356 |
| custservice@shl-tm.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
| Device Size Text, specify | 0 |
| Height | 1.5 Centimeter |
| Width | 8.5 Centimeter |
| Length | 11 Centimeter |
| Weight | 240 Gram |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290008960359 [Previous] |
| GS1 | 07290008960380 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113514
FDA Product Code
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2025-12-09 |
On-Brand Devices [Smartheart]
| 07290008960359 | The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with |
| 07290008960380 | The SmartHeart is a portable battery powered, 12-lead ECG and rhythm strip device with Bluetooth |
Trademark Results [Smartheart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTHEART 86896543 not registered Live/Pending |
Veridian Healthcare, LLC 2016-02-03 |
 SMARTHEART 86263520 not registered Dead/Abandoned |
Shaklee Corporation 2014-04-25 |
 SMARTHEART 77930173 not registered Dead/Abandoned |
Normerica Inc. 2010-02-08 |
 SMARTHEART 77362600 not registered Dead/Abandoned |
DROLSHAGEN, BRIDGET M. 2008-01-02 |
 SMARTHEART 74526162 1990670 Dead/Cancelled |
HARLEY STREET SOFTWARE LTD. 1994-05-18 |
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