Data / Medical devices / Israel / Sofwave Medical Ltd.

Sofwave Medical Ltd.: FDA-registered device maker in Yokneam Illit Northern, Israel, 12 510(k) clearances

Name: Sofwave Medical Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sofwave Medical Ltd. is registered with the FDA (registration 3015889734) in Yokneam Illit Northern, Israel. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated July 2, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015889734
Address: HaOtsma 1 POB 157, Yokneam Illit Northern, Israel, 2069203
Owner or operator: Sofwave Medical Ltd. (10061304)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: October 7, 2019
Registered through: 2027
Brand names listed: Pure Impact VIP, SofWave, Sofwave, Sofwave System

Devices it lists

Device	Product code	Class	Role	Source
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	OHV	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US, 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
July 2, 2025	K251746	Pure Impact	NGX	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
April 18, 2025	K250146	SofWave System	NGX	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
August 7, 2024	K241685	SofWave System	NGX	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
May 30, 2024	K240687	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
December 22, 2023	K233104	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
December 14, 2023	K232455	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
August 28, 2023	K231537	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
April 18, 2023	K230820	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
March 14, 2023	K230019	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
December 16, 2022	K223237	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
November 15, 2021	K211483	SofWave System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
September 9, 2019	K191421	Sofacia System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2025. 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.