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AT-Patch (ATP-C130/ATP-C70)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242583

by ATsens.co., Ltd.

Identifiers

510(k) Number
K242583 FDA 510(k)
FDA Product Code
DSH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2800 FDA 510(k)
Regulation Number
870.2800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AT-Patch (ATP-C130/ATP-C70) is a recorder, magnetic tape, medical device classified under product code DSH and regulation number 870.2800. It is a wearable electrocardiogram (ECG) monitor designed for long-term continuous cardiac monitoring, providing up to 14 days (ATP-C130) or 7 days (ATP-C70) of uninterrupted ECG recording to detect arrhythmias and other cardiac events.

The device is supplied by ATsens.co., Ltd. and received FDA 510(k) clearance under K-number K242583, with a decision date of May 2, 2025. It is classified as a Class II medical device with product code DSH and is intended for use in cardiovascular monitoring settings. No information regarding sterility, single-use or reusable status, MRI safety, storage conditions, or additional sizes is provided in the data.

Frequently asked questions

What duration of continuous ECG monitoring does each AT-Patch model provide?

The AT-Patch comes in two models: ATP‑C130 records up to 14 days continuously, while ATP‑C70 records up to 7 days. This is stated in the description, which specifies the respective monitoring periods for each model.

How is the AT-Patch supplied and who is the manufacturer?

The device is supplied by ATsens.co., Ltd., the listed manufacturer. The data lists the company name and address, confirming that ATsens.co., Ltd. provides the AT‑Patch to customers.

What regulatory classification and clearance does the AT-Patch have?

The AT‑Patch is classified as a Class II medical device with product code DSH, and it received FDA 510(k) clearance (K‑number K242583) on May 2 2025. This information is directly taken from the regulatory details provided.

Is there any information about sterility, single‑use, or reuse status for the AT-Patch?

The supplied data does not mention sterility, nor does it indicate whether the AT‑Patch is single‑use or reusable. Because no such details are provided, we cannot state any status regarding these attributes.

What clinical setting is the AT-Patch intended for?

The description states the AT‑Patch is intended for cardiovascular monitoring settings, specifically for long‑term continuous cardiac monitoring to detect arrhythmias and other cardiac events. This defines its clinical use without implying regulatory claims.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AT-Patch (ATP-C130/ATP-C70) (K242583) — FDA 510(k) | Innolitics, AT-Patch (ATP-C130/ATP-C70) - physicianaitools.com, AT-Patch (ATP-C130/ATP-C70) | FDA Radiology AI Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
ATsens.co., Ltd.
FDA Applicant
Atsens Co., Ltd.

Sources (1)

  • FDA 510(k) K242583 24 fields · synced Sep 19, 2026