Patient Lead Wire
Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads (…
Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54″ (1,37m)), 2 long leg leads (56″ (1,42m)), 2 long 1 into 3 Trident leads ( 42″(1,07m)), 2 lead separators, 2.54 DIA, 10 banana post adapters, 2 Trident Yoke labels (C1-C3, C4-C6), 4 colored clips, 14x colored rings, 6 white base rings and instructions for use. This lead set comes fully assembled. 1 complete lead set = 1 sales unit
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Record published | 2026-03-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 57.2 to 101.4 KiloPascal; Storage environment humidity 10 to 90 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TC ADDITIONAL LONG LEADS KIT: IEC | In distribution | |
| PW TC20 Long 10-Lead Patient Cable IEC | In distribution | |
| PW CBL Long Complete Lead Set IEC | In distribution | |
| PW TC20 Long 10-Lead Patient Cable AHA | In distribution | |
| Long 10-lead Patient Cable IEC | In distribution | |
| TC ADDITIONAL LONG LEADS KIT: AAMI | In distribution | |
| PW CBL Complete Lead Set AAMI | In distribution | |
| TC ADDITIONAL LEADS KIT: AAMI | In distribution | |
| 12-Lead Patient Cable (AAMI), Long | In distribution | |
| Chest Lead Set, AAMI/IEC | In distribution | |
| PW TC20 10-Lead Patient Cable AHA | In distribution | |
| Long Complete Lead Set AAMI | In distribution | |
| Long Limb Lead Set (Both AAMI and IEC) | In distribution | |
| 12-Lead Patient Cable (AAMI), Std Length | In distribution | |
| Standard 10-lead Patient Cable IEC | In distribution | |
| PW TC20 10-Lead Patient Cable IEC | In distribution | |
| Long Chest Lead Set (Both AAMI and IEC) | In distribution | |
| Limb Lead Set (Both AAMI and IEC) | In distribution | |
| TC ADDITIONAL LEADS KIT: IEC | In distribution | |
| PW CBL Complete Lead Set IEC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241556 | 2024-12-17 |
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.