510(k) K251746— Pure Impact

Substantially Equivalent

Sofwave Medical, Ltd.

Clearance details

Applicant: Sofwave Medical, Ltd.
Product code: Code NGX
Advisory panel: Physical Medicine
Date received: 2025-06-06
Decision date: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam Iiit, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.