AT-Patch

Basic Information

• Brand Name: AT-Patch
• Primary DI: 08800069700260
• Version / Model: ATP-C130
• Company Name: ATsens Co., Ltd.
• Labeler DUNS: 696621857
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-05
• Public Version: 2
• Public Version Date: 2025-11-14
• Public Version Status: Update
• Public Device Record Key: 0299a1a6-9a81-4d80-90b7-9d6a3ee70293

Device Description

The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for longterm recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	870.2800	2
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800069700260	GS1

Premarket Submissions

Submission Number	Supplement Number
K242583	000