ClearanceBrief
Company ยท IL

Sofwave Medical, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption9
NGXStimulator, Muscle, Powered, For Muscle Conditioning3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 2, 2025K251746Pure Impact
Sofwave Medical, Ltd., IL
NGX
Apr 18, 2025K250146SofWave System
Sofwave Medical, Ltd., IL
NGX
Aug 7, 2024K241685SofWave System
Sofwave Medical, Ltd., IL
NGX
May 30, 2024K240687SofWave System
Sofwave Medical, Ltd., IL
OHV
Dec 22, 2023K233104SofWave System
Sofwave Medical, Ltd., IL
OHV
Dec 14, 2023K232455SofWave System
Sofwave Medical, Ltd., IL
OHV
Aug 28, 2023K231537SofWave System
Sofwave Medical, Ltd., IL
OHV
Apr 18, 2023K230820SofWave System
Sofwave Medical, Ltd., IL
OHV
Mar 14, 2023K230019SofWave System
Sofwave Medical, Ltd., IL
OHV
Dec 16, 2022K223237SofWave System
Sofwave Medical, Ltd., IL
OHV
Nov 15, 2021K211483SofWave System
Sofwave Medical, Ltd., IL
OHV
Sep 9, 2019K191421Sofacia System
Sofwave Medical, Ltd., IL
OHV

Latest recalls

DateFirm and productCodeLinked 510(k)
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