Mini Telemetry System
Mini Telemetry System wirelessly transfers fetal or maternal monitoring signals from an ambulatory mother to a compatible monitor. A body-worn transmitter receives signals from connected…
Mini Telemetry System wirelessly transfers fetal or maternal monitoring signals from an ambulatory mother to a compatible monitor. A body-worn transmitter receives signals from connected transducers and sends them to a receiver beside the monitor.
Supported inputs include ultrasound fetal heart rate, fetal or maternal ECG and uterine activity measured through TOCO or intrauterine-pressure sensing. Inputs can be monitored separately or in combination.
Transmitter and Receiver
The transmitter is carried with a strap while the receiver remains connected near the compatible Corometrics monitor. The telemetry system is an accessory to that monitor, intended for supervised use within a defined coverage area during antepartum monitoring or labour.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1), Shandong (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 |
| Luen Hing Textile -Shangyu Manufacturing(ZHONG Shan) Co Ltd | Zhongshan | Guangdong | Contract manufacturer | 2 |
| 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 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Wipro GE Healthcare Private Ltd., India |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K110556 |
| Record published | 2016-06-24 |
| Record revised | 2026-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2051444-003 | In distribution | |
| 2051440-004 | In distribution | |
| 2051444-001 | In distribution | |
| 2051444-002 | In distribution | |
| 2051440-002 | In distribution | |
| 2051444-004 | In distribution | |
| 2051440-001 | In distribution | |
| 2051440-003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 137 |
| Sonicaid | Huntleigh Healthcare Ltd. | 39 |
| Obix | Huntleigh Healthcare Ltd. | 33 |
| Ameritus Transducer | Kentec Medical, LLC | 28 |
| Fetal Monitor Remote Display | Clinicomp Intl., Inc. | 18 |
| Tenacore | Tenacore LLC | 11 |
| FetaLink | Cerner Corporation | 9 |
| PeriWatch Vigilance® HUB™ | PeriGen Solutions Ltd. | 9 |
| Dopplex | Huntleigh Healthcare Ltd. | 9 |
| Natus Neurology | Natus Neurology Incorporated | 8 |
| Fetal & maternal monitor | Edan Instruments, Inc. | 8 |
| PeriWatch Vigilance® Curve™ | PeriGen Solutions Ltd. | 8 |
Showing 12 of 117. All products under System, Monitoring, Perinatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110556 | 2011-07-19 |
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.