Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006697681

FEI Number

3006697681

Entity Name

PINE MOON ELECTRONICS CO., LTD.

City/State/Country

SHENZHEN CITY Guangdong, CN

Establishment Address

SIXTH AND SEVENTH FLOOR, BUILDING B, EIGHTH FLOOR BUILDING A, 22ND HUANPING ROAD, GAOQIAO COMMUNITY, PINGDI STREET, LONGGANG DISTRICT, SHENZHEN CITY Guangdong 518117, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

PressOn Electrode for Prolonged Use Fine Wire Electrode Reusable Dual Disc Bar Recording Electrode Disposable Alligator Clips Reusable, Nonsterile Extension and Adaptor Cables Nonsterile, Reusable Alligator Clips RLI CUTANEOUS DISPOSABLE ELECTRODE RHYTHMLINK DISC ELECTRODES RHYTHMLINK INTL. SUBD Guardian Needle Electrode Disposable Concentric Needle RLI CUTANEOUS DISPOSABLE ELECTRODE RHYTHMLINK DISC ELECTRODES Detachable Disposable Monopolar Needle Electrode MSP Low Profile EEG Needle Electrode MR Conditional Sticky Pad Electrode EMG Recording Ring Electrode MR Conditional Web Electrode MR Conditional Cup Electrode Disposable Monopolar Needle Electrode MR Conditional Quick Connect System BrainHealth Headset RLSP210 MSP RLSP210-03 MSP Disposable Rhythmlink Template

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2012-07-16
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-12
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2021-07-09
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2015-04-08
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-07-16
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2007-07-16
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2020-05-28
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
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-09
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-04-07
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2021-07-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-02-10
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-07-12
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2013-06-13
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2021-07-09
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-11-12
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2019-09-23
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-05-01
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-08-30

Official Correspondent

Sandra O'Reilly

US Agent Details

Sandra O'Reilly Business: Rhythmlink International LLC Email: quality@rhythmlink.com Phone: (678) 3341720

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
1067162	RHYTHMLINK INTERNATIONAL, LLC	Columbia, SC, US

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.

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9610691	Ambu A/S	Ballerup Hovedstaden, DK
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006697681. Last updated year: 2026. Please use registration number 3006697681 when referencing this establishment in official correspondence.