Data / Medical devices / Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (JOM): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM, Class 2, 21 CFR 870.2780). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on October 20, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOM
- Device class
- 2
- Regulation
- 870.2780
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 2 |
| Bulgaria | 1 |
| Slovenia | 1 |
| South Korea | 1 |
| United Kingdom | 1 |
| Brazil | 1 |
Makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
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 |
|---|---|---|---|---|---|---|---|---|
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 3 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Mesi D.O.O. | Ljubljana, Slovenia | Manufacturer | 3 | April 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Collaborative Care Diagnostics LLC dba BioMedix | Eagan, MN, United States | Complaint file establishment, Specification developer | 2 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| D. E. Hokanson, Inc. | Bellevue, WA, United States | Manufacturer | 2 | February 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medicore Co. Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | June 13, 2011 | 0 | 0 | 0 | api.fda.gov |
| Huntleigh Healthcare Ltd. | Cardiff, South Glamorgan, United Kingdom | Complaint file establishment, Manufacturer | 1 | January 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| LD Technology LLC | Miami, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | December 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Semler Scientific, Inc. | Campbell, CA, United States | Manufacturer | 1 | March 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medeologix LLC | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ontogen Manufacturing LLC | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parks Medical Electronics, Inc. | Aloha, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 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 | |
| Philips North America LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 20, 2022. 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.