ReDS Pro System
The ReDS Pro V2.7 system measures lung fluid content without entering the body. Qualified healthcare practitioners use it under a physician’s direction to monitor patients with…
The ReDS Pro V2.7 system measures lung fluid content without entering the body. Qualified healthcare practitioners use it under a physician’s direction to monitor patients with fluid-management problems in hospitals, hospital-type facilities and homes, including patients taking diuretics or living with heart failure.
Two sensors in an adjustable clip-like unit sit at the front and back of the chest. Low-power electromagnetic signals pass through the thorax, and measured wave impedance indicates tissue fluid content. A connected bedside console analyzes the signals and displays lung fluid as a volume percentage.
Listed Item
Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting
Patient Size Range
The system covers heights from 155 to 195cm and BMI from 22 to 36. Patients within that height range with BMI from 36 to 38 may use it if the device’s chest-size ruler reading is 39 or less.
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Sensible Medical Innovations Ltd., Israel |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Manufacturer |
| 510(k) | K180479 |
| Record published | 2020-07-02 |
| Record revised | 2024-10-11 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 0 to 93 % RH; Storage environment temperature 32 to 122 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 41 to 95 °F |
| Distribution end date | 2022-06-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V2.7 | In distribution | |
| V2.7 | In distribution | |
| V2.7 | In distribution | |
| V2.7 | Withdrawn | |
| V2.7 | Withdrawn | |
| V2.76 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| Hokanson | D. E. Hokanson, Inc. | 11 |
| EV1000 | Edwards Lifesciences Technology Sarl | 9 |
| Valhalla Scientific, Inc | Valhalla Scientific, Inc. | 9 |
| ReDS System | Sensible Medical Innovations Ltd. | 7 |
| Avivo™ | Medtronic, Inc. | 3 |
| ICG cable | Cnsystems Medizintechnik GmbH | 3 |
| ECG cable | Cnsystems Medizintechnik GmbH | 3 |
| PhysioFlow | Manatec | 3 |
| uCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 3 |
| ReDS Wearable System | Sensible Medical Innovations Ltd. | 3 |
| Flying-V – finger cuff (medium) | Cnsystems Medizintechnik GmbH | 3 |
Showing 12 of 66. All products under Plethysmograph, Impedance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180479 | 2019-02-28 |
| K150095 | 2015-08-06 |
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.