TeleSenseRCM
The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously…
The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are: – Cardiology – Pulmonary Care – Home Care – General Practitioners Contraindications: a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring. b. Patients who the attending physician thinks should be hospitalized.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 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 |
| Dongguan CFE Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Chero Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Hangzhou VivaLNK Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 4 |
Record
| Listed by | Scottcare Corporation, THE |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| 510(k) | K142180 |
| Record published | 2016-09-19 |
| Record revised | 2019-11-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 40 °C; Handling environment temperature -20 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCT1774 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Sync | Covidien LP | 29 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden Corp. | 22 |
| LifeSync | LifeSync Corporation | 18 |
| Surveyor Patient Cable | Mortara Instrument, Inc. | 18 |
| Isansys | Isansys Lifecare, Ltd. | 15 |
| ZephyrLIFE Home | Zephyr Technology Corporation | 11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden America, Inc. | 9 |
| InTouch Health | Intouch Health, Inc. | 7 |
| UbiqVue | LifeSignals, Inc. | 6 |
| X12+ | Mortara Instrument, Inc. | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 5 |
| Ezypro ECG Recorder | Sigknow Biomedical Co., Ltd. | 3 |
Showing 12 of 211. All products under Transmitters And Receivers, Physiological Signal, Radiofrequency
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.