Anne Chest Sensor Kit
ANNE Chest is a wearable wireless sensor that records ECG waveforms, heart rate, respiratory rate, activity, body position and skin temperature, and detects falls. It provides continuous…
ANNE Chest is a wearable wireless sensor that records ECG waveforms, heart rate, respiratory rate, activity, body position and skin temperature, and detects falls. It provides continuous physiological information to healthcare professionals caring for general care patients aged 12 years or older in clinical or home settings.
The skin-mounted sensor collects ECG, three-axis acceleration and temperature signals. It sends data by Bluetooth to compatible software for display, storage and analysis. The sensor is reusable across patients following the required cleaning process.
Listed Item
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Measurement Conditions
Respiratory rate is not measured during significant motion or activity. The device is not intended for critical care patients, and its ECG signal is not intended for manual discrimination of arrhythmias or cardiac conditions.
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 | Sibel Health Inc., United States |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Establishment | Manufacturer |
| 510(k) | K240251 |
| Record published | 2025-03-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900-00007 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240251 | 2024-06-03 |
| K223711 | 2023-08-10 |
| K221530 | 2022-11-22 |
| K211305 | 2021-09-14 |
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.