Pure Impact
K-Number: K251746 · 2025-07-02
Device Summary
Frequently Asked Questions
What is the Pure Impact?
Pure Impact is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Sofwave Medical, Ltd.. The 510(k) number is K251746.
When did Pure Impact receive FDA 510(k) clearance?
Pure Impact received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251746.
Who is the listed applicant for Pure Impact?
The FDA 510(k) record lists Sofwave Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pure Impact?
The FDA product code for Pure Impact is NGX.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Sofwave Medical, Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NGX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.