SOFWAVE MEDICAL LTD

Israel IL-MF-000019200 Last updated 25 May 2026

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Devices: 24
Registries: EUDAMEDGUDIDFDA 510(k)
FDA recalls: 0

Catalogue24

SofWave Pure Impact Wireless Stimulation Module FG00014-R Ref FG00014-R

Class II FDA UDI Active
Pure Impact KT00040 Ref KT00040

Class II FDA UDI Active
Pure Impact Touch control Module FG00016 Ref FG00016

Class II FDA UDI Active
Sofwave Applicator FG00002 Ref FG00002

Class II FDA UDI Active
SofWave Pure Impact Electode Pads FG00015 Ref FG00015

Class II FDA UDI Active
SofWave Pure Impact Stimulation Modules Charging Station FG00013 Ref FG00013

Class III FDA UDI Active
Sofwave Applicator FG00003-R Ref FG00003-R

Class II FDA UDI Active
Sofwave Applicator FG00002-R Ref FG00002-R

Class II FDA UDI Active
Sofwave Applicator FG00003 Ref FG00003

Class II FDA UDI Active
Sofwave Applicator FG00004 Ref FG00004

Class II FDA UDI Active
SofWave Pure Impact Wireless Stimulation Module FG00014 Ref FG00014

Class II FDA UDI Active
SofWave System Ref K230019

Class II FDA 510(k) Active
Sofacia System Ref K191421

Class II FDA 510(k) Active
SofWave System Ref K241685

Class II FDA 510(k) Active
SofWave System Ref K233104

Class II FDA 510(k) Active
SofWave System Ref K211483

Class II FDA 510(k) Active
SofWave System Ref K240687

Class II FDA 510(k) Active
SofWave System Ref K231537

Class II FDA 510(k) Active
SofWave System Ref K223237

Class II FDA 510(k) Active
SofWave System Ref K230820

Class II FDA 510(k) Active
SofWave System Ref K232455

Class II FDA 510(k) Active
SofWave System Ref K250146

Class II FDA 510(k) Active
Pure Impact Ref K251746

Class II FDA 510(k) Active
Sofwave Ref FG00001INT

Class IIa EUDAMEDFDA UDI Active

Authorised representatives

Obelis s.a. BE

What SOFWAVE MEDICAL LTD makes

SofWave Medical Ltd manufactures ultrasonic skin contouring systems designed for non-invasive body sculpting, alongside transcutaneous neuromuscular electrical stimulation (TENS) devices for physical therapy. Their product line includes control modules, applicators, electrode pads, and wireless stimulation modules tailored for aesthetic and rehabilitative applications. The systems integrate hardware components like applicators and charging stations to deliver targeted treatments.

The company’s devices are classified under EU Class II, Class III, and Class IIa regulations, with listings in the EUDAMED registry, FDA’s 510(k) clearance database, and FDA’s Unique Device Identifier (UDI) system. The portfolio is regulated under medical device directives applicable to both aesthetic and therapeutic applications, ensuring compliance with international standards for safety and performance.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Israel
Address: 1, Ha-Otsma st., Yokneam Illit, Israel
Website: sofwave.com/
Email: [email protected]
Phone: +972-73-2017650
PRRC contact: Ruthie Amir
EUDAMED SRN: IL-MF-000019200
DUNS number: 531962539

Catalogue24

SofWave Pure Impact Wireless Stimulation Module FG00014-R Ref FG00014-R

Pure Impact KT00040 Ref KT00040

Pure Impact Touch control Module FG00016 Ref FG00016

Sofwave Applicator FG00002 Ref FG00002

SofWave Pure Impact Electode Pads FG00015 Ref FG00015

SofWave Pure Impact Stimulation Modules Charging Station FG00013 Ref FG00013

Sofwave Applicator FG00003-R Ref FG00003-R

Sofwave Applicator FG00002-R Ref FG00002-R

Sofwave Applicator FG00003 Ref FG00003

Sofwave Applicator FG00004 Ref FG00004

SofWave Pure Impact Wireless Stimulation Module FG00014 Ref FG00014

SofWave System Ref K230019

Sofacia System Ref K191421

SofWave System Ref K241685

SofWave System Ref K233104

SofWave System Ref K211483

SofWave System Ref K240687

SofWave System Ref K231537

SofWave System Ref K223237

SofWave System Ref K230820

SofWave System Ref K232455

SofWave System Ref K250146

Pure Impact Ref K251746

Sofwave Ref FG00001INT

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Authorised representatives

What SOFWAVE MEDICAL LTD makes

Information