FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312025071
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
110-725
Device description
35 Detachable Monopolar Needle Electrodes, EMG, 25mm x 27g with 2 Detachable Reusable Adapter Cables
Published
2022-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816312025071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312025071008163120250718163120250710816312025071

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

DUNS number
126290993
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816312028673Rhythmlink®RLSP5642026-09-21
00816312027822Rhythmlink®MRQD207071522026-06-10
00816312028072Rhythmlink®MRQW20908152026-06-01
00816312024401RHYTHMLINK INTERNATIONAL, LLCRLSP5332022-01-12
00816312028065Rhythmlink®MRQWS423152026-05-18
10816312028048Rhythmlink®MRDC25152026-03-30
10816312027966Rhythmlink®DC31152026-02-13
00816312027969Rhythmlink®DC31152026-02-13
10816312027959Rhythmlink®DC2415202026-01-12
00816312027945Rhythmlink®MRQWD3040405152026-01-12
00816312025910Rhythmlink®SP2100012021-08-06
00816312027921Rhythmlink®MRQD31006101522025-12-08
00816312027853Rhythmlink®CTGN2121-2.52025-12-05
10816312027850Rhythmlink®CTGN2121-2.52025-12-05
00816312027860Rhythmlink®CTGN2121-2.52025-12-03
10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027907Rhythmlink®DCDECUL3315202025-11-21
00816312027914Rhythmlink®SCDECUS2610152025-11-21
10816312027898Rhythmlink®DC29152025-11-07
10816312023104Rhythmlink®RLSP5222020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14