ECG Cables and Leadsets

Philips reusable ECG cables and lead sets carry cardiac electrical signals from skin electrodes to compatible monitoring or diagnostic equipment. They are accessories for healthcare…

Registry build 21.09.26

Philips reusable ECG cables and lead sets carry cardiac electrical signals from skin electrodes to compatible monitoring or diagnostic equipment. They are accessories for healthcare professionals caring for adult, pediatric and neonatal patients, with their use limited by the connected equipment’s indications.

Electrical wires form the signal pathway between the electrodes, patient lead set and trunk cable. The portfolio includes intensive-care and operating-room configurations, with different electrode connectors and AAMI or IEC color identification.

Listed Item

OR 3-Lead ECG Trunk Cable, AAMI/IEC

Compatibility and Reuse

The nonsterile cables and lead sets are designed for use with multiple patients. Operating-room trunk cables support ECG monitoring during electrosurgery when combined with a compatible patient lead set and compatible Philips monitoring equipment.

22manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DSA
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Ningbo Xinwell Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 12
APK Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
ABA Medical Technology Co Ltd Guang Dong Guangdong Contract manufacturer 6
Beijing Rongrui Century Science Technology Co., Ltd. Beijing Beijing Contract manufacturer 4
Dongguan Rongrui-Century Science&Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Ruibaolian Medical Science & Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Kepler Special Cabling Company Limited Dongguan Guangdong Contract manufacturer 3
Palconn Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
Shenzhen Redy-MED Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)

Record

Regulatory record for ECG Cables and Leadsets
Listed by Philips Medizin Systeme Böblingen GmbH, Germany
FDA product code DSA
Device type Cable, Transducer And Electrode, Patient, (Including Connector)
Device class Class 2
Regulation 21 CFR 870.2900
510(k) K243545
Record published 2025-10-28

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number
Storage Storage environment temperature -20 to 70 °C; Storage environment temperature -4 to 158 °F; Storage environment atmospheric pressure 10 to 108 KiloPascal; Storage environment humidity 15 to 95 % RH
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ECG Cables and Leadsets
Catalogue number Size Status
5 Lead ECG Trunk Cable, AAMI/IEC In distribution
6 Lead Set Grabber AAMI, ICU In distribution
6+4 Lead ECG Trunk, AAMI/IEC In distribution
OR 3-Lead ECG Trunk Cable, AAMI/IEC In distribution
5 Lead Snap Chest AAMI, ICU In distribution
5+5 ECG Trunk cable AAMI, IEC In distribution
6 Lead ECG Trunk, AAMI/IEC In distribution
3 Leadset, Grabber, AAMI, ICU In distribution
10 Lead ECG Trunk, AAMI/IEC In distribution
5 Leadset, Grabber,Chest, AAMI,ICU In distribution
CBL 5 Leadset, Snap, AAMI, ICU In distribution
CBL 4 Lead Set Grabber AAMI, ICU In distribution
5 Leadset, Grabber, Chest, AAMI, OR In distribution
Unshielded 3 Ld Miniclip AAMI In distribution
3 Lead ECG Trunk Cable, AAMI/IEC In distribution
3 Leadset, Grabber, AAMI, OR In distribution
3 Leadset, Snap, AAMI, ICU In distribution
5 Leadset, Grabber, AAMI, ICU In distribution
5 Leadset, Snap, AAMI, ICU In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 5,928
AMC LifeSync Corporation 1,058
Fogg System Company, Inc. Fogg System Company, Inc. 693
Multi-Link™ AirLife Finland Oy 611
Cable, Transducer And Electrode, Patient, (Including Connector) ConMed Corporation 284
Maguire Maguire Enterprises, Inc. 193
MediChoice Owens & Minor Distribution, Inc. 160
Vermed Graphic Controls Acquisition Corporation 159
Vital Signs™ AirLife Finland Oy 136
Multi-Link™ Carefusion Finland 320 Oy 136
Med-link Shenzhen MED-Link Electronics Tech Co., Ltd. 129
Conmed ConMed Corporation 106

Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243545 2025-01-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer