Nerivio; Nerivio Infinity
K-Number: K250405 · 2025-05-14
Device Summary
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. The listed applicant is Theranica Bio-Electronics, Ltd.. The 510(k) number is K250405.
When did Nerivio; Nerivio Infinity receive FDA 510(k) clearance?
Nerivio; Nerivio Infinity received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250405.
Who is the listed applicant for Nerivio; Nerivio Infinity?
The FDA 510(k) record lists Theranica Bio-Electronics, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nerivio; Nerivio Infinity?
The FDA product code for Nerivio; Nerivio Infinity is QGT.
Other records listing Theranica Bio-Electronics, 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: QGT)
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.