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Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track…
Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
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 | Impedimed Limited, Australia |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2023-08-03 |
| Record revised | 2026-04-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V 5.0.0 | In distribution |
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 |
| ReDS Pro System | Sensible Medical Innovations Ltd. | 6 |
| 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 |
Showing 12 of 66. All products under Plethysmograph, Impedance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260224 | 2026-08-17 |
| K232089 | 2023-10-17 |
| K203473 | 2021-04-19 |
| K193410 | 2020-10-02 |
| K172507 | 2017-12-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Impedimed Limited | UDI-DI | 2023-08-17 | Class II | Device Design | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result | 354 |
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.