K1000

Basic Information

• Brand Name: K1000
• Primary DI: B210AC0290
• Version / Model: AC-029
• Company Name: Alivecor, Inc.
• Labeler DUNS: 078523613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-18
• Public Version: 2
• Public Version Date: 2026-01-09
• Public Version Status: Update
• Public Device Record Key: 5ac90fa2-b9bc-4055-b92d-289dea20d914

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPS	Electrocardiograph	Cardiovascular	870.2340	2
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16231	Electrocardiograph, professional, multichannel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B210AC0290	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 45 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity