TelePatch Cardiac Monitor

FDA UDI

Class II (US FDA UDI)

by Medicomp, Inc.

Identity

Trade Name: TelePatch Cardiac Monitor FDA UDI
Generic Name: Electrocardiograph, home-use FDA UDI
Device Name: TelePatch CM PM800 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. FDA UDI
Model / Reference: PM800 FDA UDI
Description: TelePatch CM PM800 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. FDA UDI

Identifiers

Primary DI / UDI-DI: 00862887000319 FDA UDI
510(k) Number: K161916 FDA UDI
FDA Product Code: DRG FDA UDI
MLO FDA UDI
GMDN Term: Electrocardiograph, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2910 FDA UDI
870.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiograph, home-use

TelePatch Cardiac Monitor by Medicomp, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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System Cable — Kestra Medical Technologies, Inc. · Class II

Cleared under the same submission

K161916 also covers:

TelePatch Cardiac Monitor — MEDICOMP, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medicomp, Inc.

Sources (1)

FDA UDI 98851a7a-764b-4a7c-81e9-b134fbd0d51f 36 fields · synced Jun 8, 2026