Nerivio; Nerivio Infinity
K-Number: K250405 · 2025-05-14
ApplicantTheranica Bio-Electronics, Ltd.
Decision Date2025-05-14
Product CodeQGT
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Nerivio; Nerivio Infinity is a medical device manufactured by Theranica Bio-Electronics, Ltd.. It received FDA 510(k) clearance on 2025-05-14 under approval number K250405. The device is classified under product code QGT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nerivio; Nerivio Infinity?
Nerivio; Nerivio Infinity is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Theranica Bio-Electronics, Ltd.. The 510(k) number is K250405.
When was Nerivio; Nerivio Infinity approved by the FDA?
Nerivio; Nerivio Infinity received FDA 510(k) clearance on 2025-05-14, under approval number K250405.
What company makes Nerivio; Nerivio Infinity?
Nerivio; Nerivio Infinity is manufactured by Theranica Bio-Electronics, Ltd..
What is the FDA product code for Nerivio; Nerivio Infinity?
The FDA product code for Nerivio; Nerivio Infinity is QGT.
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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.