Data / Medical devices / Israel / Commwell Research And Development Ltd
Commwell Research And Development Ltd: FDA-registered device maker in kfar saba Central, Israel, 6 510(k) clearances
Commwell Research And Development Ltd is registered with the FDA (registration 3008881835) in kfar saba Central, Israel. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 18, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008881835
- Address
- yad haruzim 4, kfar saba Central, Israel, 44641
- Owner or operator
- Commwell Research and Development Ltd (10035078)
- Roles
- Manufacturer
- First device listed
- February 1, 2011
- Registered through
- 2026
- Brand names listed
- ECG SETINEL System, Health e-Care, PHYSIOGLOVE ES, PHYSIOGLOVE ES WITH ECG ANALYSIS, PHYSIOGLOVE ET SYSTEM, PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1, REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2017 | K172801 | ECG SENTINEL System | DXH | Substantially Equivalent | Cardiomedix, Inc. | accessdata.fda.gov |
| August 18, 2014 | K133703 | PHYSIOGLOVE ET SYSTEM | DXH | Substantially Equivalent | Commwell R&D , Ltd. | accessdata.fda.gov |
| October 21, 2011 | K103791 | PHYSIOGLOVE ES WITH ECG ANALYSIS | DPS | Substantially Equivalent | Commwell , Ltd. | accessdata.fda.gov |
| March 10, 2009 | K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | DRX | Substantially Equivalent | Commwell , Ltd. | accessdata.fda.gov |
| April 25, 2006 | K050674 | PHYSIOGLOVE ES | DPS | Substantially Equivalent | Commwell , Ltd. | accessdata.fda.gov |
| June 8, 2001 | K010791 | REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) | DXH | Substantially Equivalent | Adsis , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrode, Electrocardiograph
- All makers of Electrocardiograph
- All makers of Medical Device Data System
Updated October 18, 2017. 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.