K1000
GUDID B210AC0290
K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional more data than a single lead EKG. K1000 has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to a smartphone or tablet. K1000 is available by prescription only.
Alivecor, Inc.
Electrocardiograph, professional, single-channel| Primary Device ID | B210AC0290 |
| NIH Device Record Key | 5ac90fa2-b9bc-4055-b92d-289dea20d914 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K1000 |
| Version Model Number | AC-029 |
| Company DUNS | 078523613 |
| Company Name | Alivecor, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com | |
| Phone | (844) 620-1060 |
| clinicalsupport@alivecor.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B210AC0290 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210753
FDA Product Code
| DPS | Electrocardiograph |
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 | 2025-03-26 |
| Device Publish Date | 2025-03-18 |
Devices Manufactured by Alivecor, Inc.
| B210AC0290 - K1000 | 2025-03-26K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional more data than a single lead EKG. K1000 has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to a smartphone or tablet. K1000 is available by prescription only. |
| B210AC0290 - K1000 | 2025-03-26 K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional |
| B210AC0270 - Kardia 12L | 2024-08-21 Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using softwar |
| B210AC0110 - KardiaBand System | 2024-04-01 The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, st |
| B210AC0210 - KardiaMobile Card | 2022-07-21 The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, tran |
| B210AC0190 - KardiaMobile 6L | 2020-05-11 |
| B210AC0090 - Kardia Mobile | 2018-07-06 |
Trademark Results [K1000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K1000 74211496 1715258 Dead/Cancelled |
Asahi Kogaku Kogyo Kabushiki Kaisha 1991-10-09 |
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