SOFWAVE MEDICAL LTD.

FDA Device Registration & Listing · Yokneam Illit Northern, IL · Registration 3015889734

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015889734
FEI Number
3015889734
Entity Name
SOFWAVE MEDICAL LTD.
City/State/Country
Yokneam Illit Northern, IL
Establishment Address
HaOtsma 1, POB 157, Yokneam Illit Northern 2069203, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sofwave Medical Ltd. (Owner Number: 10061304)
Owner / Operator Contact Address
HaOtsma 1, POB 157, Yokneam Illit, IL-NOTA 2069203, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241685
PMA Number
N/A

All Registered Proprietary Names

Sofwave Pure Impact VIP Sofwave SofWave Sofwave Sofwave Sofwave System Sofwave SofWave

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2023-04-20
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-09-03
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-07-13
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2025-07-13
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2023-04-24
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-12-27
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2023-12-27
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2023-02-22
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2021-11-24
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2019-10-07
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2024-11-06
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2024-11-06

Official Correspondent

Erez Panir

US Agent Details

Isaac Elkah Business: Preferred Depot Email: Isaac.elkah@preferreddepot.com Phone: (844) 7702727

Related Public Records

Same Entity

Sofwave Medical Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015889734. Last updated year: 2026. Please use registration number 3015889734 when referencing this establishment in official correspondence.
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