510(k) K250146— SofWave System

Substantially Equivalent

Sofwave Medical, Ltd.

Clearance details

Applicant: Sofwave Medical, Ltd.
Product code: Code NGX
Advisory panel: Physical Medicine
Date received: 2025-01-21
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Iiit, IL

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