Pure Impact— 510(k) K251746

Substantially Equivalent

Sofwave Medical, Ltd.

FDA 510(k) clearance K251746 for Pure Impact, Substantially Equivalent on 2025-07-02. Applicant: Sofwave Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Sofwave Medical, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
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 ↗

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