Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1067162

FEI Number

3003831320

Entity Name

RHYTHMLINK INTERNATIONAL, LLC

City/State/Country

Columbia, SC, US

Establishment Address

1140 FIRST ST. SOUTH, Columbia, SC 29209, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

RHYTHMLINK INTERNATIONAL, LLC (Owner Number: 9052354)

Owner / Operator Contact Address

1140 FIRST ST. SOUTH, --, Columbia, SC 29209, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120342

PMA Number

N/A

All Registered Proprietary Names

Fine Wire Electrode RLI CUTANEOUS DISPOSABLE ELECTRODE RHYTHMLINK DISC ELECTRODES RLSP210 MSP RLSP210-03 MSP RHYTHMLINK INTL. SUBD Low Profile EEG Needle Electrode Detachable Disposable Monopolar Needle Electrode MR Conditional Web Electrode MR Conditional Cup Electrode RLI CUTANEOUS DISPOSABLE ELECTRODE RHYTHMLINK DISC ELECTRODES Disposable Concentric Needle MR Conditional PressOn Electrode MSP Reusable Dual Disc Bar Recording Electrode PressOn Electrode for Prolonged Use Pep Introducer Needle Disposable Hypodermic Monopolar Needle Guardian Needle Electrode BrainHealth Headset Pep Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-12
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2005-09-21
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-05-01
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2007-07-16
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2021-07-15
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-09
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2013-06-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-07-16
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-12
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2013-08-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-04-07
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2021-07-09
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2012-07-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-06-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-06-10
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-12
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2020-05-28
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2019-09-23
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2012-07-16
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2012-07-16

Official Correspondent

Sandra O'Reilly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RHYTHMLINK INTERNATIONAL, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006697681	PINE MOON ELECTRONICS CO., LTD.	SHENZHEN CITY Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K152984	Bio Protech, Inc.	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	2016-06-03
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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1048735	STERILIZATION SERVICES OF GEORGIA, INC.	ATLANTA, GA, US
3006697681	PINE MOON ELECTRONICS CO., LTD.	SHENZHEN CITY Guangdong, CN
2953359	Sterigenics U.S. LLC	Hayward, CA, US
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1067162. Last updated year: 2026. Please use registration number 1067162 when referencing this establishment in official correspondence.