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Data / Medical devices / Israel / iPulse Medical Ltd

iPulse Medical Ltd: FDA-registered device maker in Kfar Saba Central, Israel, 2 510(k) clearances

iPulse Medical Ltd is registered with the FDA (registration 9710485) in Kfar Saba Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 4, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9710485
FEI number
3003499891
Address
23, Hata'As, Kfar Saba Central, Israel, 4442525
Owner or operator
iPulse Medical Ltd (10055273)
Roles
Manufacturer
First device listed
July 2, 2017
Registered through
2026
Brand names listed
Livia, Livia Flower Pads, Livia Flower Pads (Black), Livia Flower Pads - Extended cord (White), Livia Gel Pads (6-Months Supply)

Devices it lists

DeviceProduct codeClassRoleSource
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 4, 2020K183110LIVIANUHSubstantially EquivalentLifecare , Ltd.accessdata.fda.gov
June 28, 2017K163153LiviaNUHSubstantially EquivalentLifecare , Ltd.accessdata.fda.gov

Compare with other makers

Updated May 4, 2020. 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.