Anne Chest
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.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (1). 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 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Dongguan Smart Manufacturing Partner Electronic Company Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Sibel Health Inc., United States |
|---|---|
| FDA product code | BZQ |
| Device type | Monitor, Breathing Frequency |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Manufacturer |
| 510(k) | K240251 |
| Record published | 2025-04-02 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 810-00012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfect Fit | Dymedix Diagnostics Inc | 189 |
| Monitor, Breathing Frequency | ConMed Corporation | 106 |
| Monitor, Breathing Frequency | Salter Labs | 52 |
| Conmed | ConMed Corporation | 46 |
| Cadwell | Cadwell Industries, Inc. | 44 |
| Sensor | Respironics Inc. | 42 |
| ThermiSense | Salter Labs | 33 |
| SnuggleFit | Dymedix Diagnostics Inc | 23 |
| Braebon Cable for Disposable RIP | Braebon Medical Corp. | 5 |
| PneumoTherm | Salter Labs | 4 |
| BiNAPS | Salter Labs | 4 |
| SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice | Ambu A/S | 4 |
Showing 12 of 248. All products under Monitor, Breathing Frequency
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.