Pure Impact
K-Number: K251746 · 2025-07-02
ApplicantSofwave Medical, Ltd.
Decision Date2025-07-02
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Pure Impact is a medical device manufactured by Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2025-07-02 under approval number K251746. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pure Impact?
Pure Impact is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Sofwave Medical, Ltd.. The 510(k) number is K251746.
When was Pure Impact approved by the FDA?
Pure Impact received FDA 510(k) clearance on 2025-07-02, under approval number K251746.
What company makes Pure Impact?
Pure Impact is manufactured by Sofwave Medical, Ltd..
What is the FDA product code for Pure Impact?
The FDA product code for Pure Impact is NGX.
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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.