Softrace
Softrace Medium RTL, Neonatal/Pediatric ECG Electrode
33manufacturers in China registered for this device type
13catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (6), Zhejiang (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shanghai Yuechen Medical Supply Co..ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
Showing 12 of 33. All 33 manufacturers in China registered for Electrode, Electrocardiograph
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | DRX |
| Device type | Electrode, Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K991105 |
| Record published | 2016-09-24 |
| Record revised | 2025-11-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 41 to 95 °F; Storage environment temperature 5 to 35 °C; Storage environment humidity 30 to 75 % RH |
| Packaging | Case of 300, case of 600 |
| Distribution end date | 2023-03-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2330-003 | 300 | In distribution | |
| 2320C-003 | 300 | In distribution | |
| 2321-003 | 300 | In distribution | |
| 2320-003 | 3 | In distribution | |
| 2321C-003 | 300 | In distribution | |
| 2350-005 | 300 | In distribution | |
| 2331C-003 | 300 | In distribution | |
| 2330C-003 | 300 | In distribution | |
| 2310-003 | 300 | In distribution | |
| 2350C-005 | 600 | In distribution | |
| 2331-003 | 300 | In distribution | |
| 2350-003 | 300 | Withdrawn | |
| 2350C-003 | 300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APK | APK Technology Co., Ltd. | 113 |
| Electrode, Electrocardiograph | Fiab SPA | 109 |
| Swaromed | Tyrolmed GmbH | 93 |
| MediMax Tech | Medimax Tech Inc. | 91 |
| Kendall | Cardinal Health | 91 |
| Medline | Medline Industries, Inc. | 78 |
| AMC | LifeSync Corporation | 74 |
| Kendall | Cardinal Health 200, LLC | 73 |
| Ambu WhiteSensor | Medico Electrodes International Ltd | 51 |
| Z-Brand™ | Graphic Controls Acquisition Corporation | 48 |
| S&W | Leonhard Lang Gmbh | 47 |
| Vermed | Graphic Controls Acquisition Corporation | 45 |
Showing 12 of 337. All products under Electrode, Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091856 | 2009-08-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2003-07-30 | Not classified | Other | Separation of the sensing element from the body of the electrode. | 200,412 electrodes (# corrected 9/5/03) | 2005-03-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-23 | Not classified | Nonconforming Material/Component | Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality. | 9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wi | 2014-10-28 |
| 2003-07-30 | Not classified | Other | Separation of the sensing element from the body of the electrode. | 774,400 electrodes (# corrected 9/5/03) | 2005-03-21 |
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.