Neteera 130H-Plus
The Neteera 130H-Plus measures heart rate and respiration without touching the patient. It is intended for spot or continuous measurements in adults in healthcare facilities or at home and…
The Neteera 130H-Plus measures heart rate and respiration without touching the patient. It is intended for spot or continuous measurements in adults in healthcare facilities or at home and can also notify clinicians of bed exit.
A high frequency microradar detects small skin movements associated with cardiac and respiratory activity. It can measure through nonmetallic clothing or furniture during rest or mild movement, with mounting and measurement range options.
Clinical Review
Healthcare professionals review the measurements to inform care. The device is prescription equipment and is not intended as an alarm system for acute, life threatening situations that require intervention, such as intensive care emergencies.
Who Else Makes It
Concentrated in Guangdong (7), 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 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| 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 |
Record
| Listed by | Neteera Technologies Ltd, Israel |
|---|---|
| FDA product code | DRT |
| Device type | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Manufacturer |
| 510(k) | K231733 |
| Record published | 2026-05-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -40 to 176 °F; Storage environment humidity 0 to 75 % RH |
| Packaging | Pack of 50, pack of 300 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 210-00-101-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Model 7600 | IVY Biomedical Systems, Inc. | 82 |
| Model 7800 | IVY Biomedical Systems, Inc. | 66 |
| ECG | Zoll Medical Corporation | 30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden America, Inc. | 18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden Corp. | 12 |
| Model 7600EP | IVY Biomedical Systems, Inc. | 11 |
| Propaq M | Zoll Medical Corporation | 11 |
| Model 7700 | IVY Biomedical Systems, Inc. | 11 |
| CTM-300 | IVY Biomedical Systems, Inc. | 6 |
| Cable | Zoll Medical Corporation | 5 |
| Upmm | IVY Biomedical Systems, Inc. | 4 |
| ViSi | Sotera Wireless | 4 |
Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231733 | 2024-02-09 |
| K212143 | 2022-09-28 |
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.