Life Sensing Instruments, Inc.
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
10manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 2 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 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Life Sensing Instruments, Inc., United States |
|---|---|
| FDA product code | DSI |
| Device type | Detector And Alarm, Arrhythmia |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Manufacturer |
| 510(k) | K896967 |
| Record published | 2025-04-01 |
| Record revised | 2020-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TrensCenter 6.300 | In distribution | |
| TrensCenter 6.100 | In distribution | |
| TrensCenter VSP 1.100 | In distribution | |
| BWI-D | In distribution | |
| HTS820 Windows 11 BLE | In distribution | |
| HTS820 Windows 11 | In distribution | |
| TrensCenter 6.000 | In distribution | |
| HTS820 Windows 7 | In distribution | |
| TrensCenter VSP 1.000 | In distribution | |
| TM8B Transmitter | In distribution | |
| TrensCenter 5.400 | In distribution | |
| HTS820 Windows 10 | In distribution | |
| TrensCenter 5.300 | In distribution | |
| TM8D Transmitter | In distribution | |
| HTS820 Windows 10 BLE | In distribution | |
| TrensCenter 6.200 | In distribution | |
| T-Link Receiver | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 160 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 30 |
| Q-Tel RMS | Mortara Instrument, Inc. | 20 |
| Detector And Alarm, Arrhythmia | Philips Medical Systems Hsg | 20 |
| ECG Electrodes | Philips Medical Systems Hsg | 19 |
| Seeq™ | Medtronic, Inc. | 18 |
| NIBP Cuffs | Philips Medical Systems Hsg | 14 |
| Waveline EZ+ | Avante | 11 |
| BodyGuardian | Preventice Technologies, Inc. | 10 |
| BodyGuardian Kit | Preventice Technologies, Inc. | 8 |
| Waveline Pro+ | Avante | 7 |
| NIBP Cuffs | Philips Medizin Systeme Böblingen GmbH | 7 |
Showing 12 of 112. All products under Detector And Alarm, Arrhythmia
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.