Data / Medical devices / Plethysmograph, Impedance
Plethysmograph, Impedance (DSB): 53 FDA-registered makers in 16 countries
53 establishments in 16 countries are registered with the FDA to make Plethysmograph, Impedance (product code DSB, Class 2, 21 CFR 870.2770). 17 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 115 510(k) clearances under this code, the latest on August 17, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DSB
- Device class
- 2
- Regulation
- 870.2770
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 27 |
| China | 6 |
| Netherlands | 3 |
| Australia | 2 |
| Germany | 2 |
| Israel | 2 |
| Japan | 2 |
| France | 1 |
| Switzerland | 1 |
| Austria | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
| Finland | 1 |
| United Kingdom | 1 |
| Malaysia | 1 |
| Taiwan | 1 |
Makers of Plethysmograph, Impedance
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Seemedx, Inc | Las Vegas, NV, United States | Specification developer | 5 | January 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Impedimed Limited | Lindfield New South Wales, Australia | Manufacturer | 3 | October 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Manatec | Poissy Ile-de-France, France | Manufacturer | 3 | February 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bracco Injeneering S.A. | LAUSANNE Vaud, Switzerland | Manufacturer, Specification developer | 2 | January 27, 1998 | 0 | 0 | 0 | api.fda.gov |
| Innovamed Sphere Inc | Fall River, MA, United States | Complaint file establishment, Specification developer | 2 | June 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Osypka Medical GMBH | Berlin, Germany | Manufacturer | 2 | October 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| SENSIBLE MEDICAL INNOVATIONS Ltd. | Netanya Central, Israel | Manufacturer | 2 | February 28, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aci Medical, LLC | San Marcos, CA, United States | Manufacturer | 1 | October 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bodyport Inc. | San Francisco, CA, United States | Complaint file establishment, Specification developer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare - Aviv | Tel Aviv, Israel | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 1 | January 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| CNSYSTEMS MEDIZINTECHNIK GmbH | Graz Steiermark, Austria | Manufacturer | 1 | February 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| D. E. Hokanson, Inc. | Bellevue, WA, United States | Manufacturer | 1 | January 18, 1990 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Sonosite,inc. | Bothell, WA, United States | Remanufacturer | 1 | June 3, 2011 | 0 | 0 | 0 | api.fda.gov |
| Impedimed, Inc. | Carlsbad, CA, United States | Specification developer | 1 | October 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tanita Corp. | ITABASHI-KU Tokyo, Japan | Specification developer | 1 | November 1, 1994 | 0 | 0 | 0 | api.fda.gov |
| Tanita Corporation of Akita, Ltd | Daisen City Akita, Japan | Manufacturer | 1 | November 1, 1994 | 0 | 0 | 0 | api.fda.gov |
| Valhalla Scientific, Inc. | Poway, CA, United States | Manufacturer | 1 | January 5, 1987 | 0 | 0 | 0 | api.fda.gov |
| Acist Medical Systems, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENCHMARK ELECTRONICS San Jorge | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDR Manufacturing, Inc., DBA Keytronic | Oakdale, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demcon Production B.V. | Enschede Overijssel, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Holding B.V. | AMSTERDAM Noord-Holland, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Finapres Medical Systems B.V. | Enschede Overijssel, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OnCore Manufacturing | Westborough, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swemco | Moorestown, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uscom Limited | SYDNEY New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Manufacturing Corporation | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.