FlexBand; FlexPatch; FlexBand Plus
K-Number: K230316 · 2023-05-26
ApplicantInternational Life Sciences
Decision Date2023-05-26
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FlexBand; FlexPatch; FlexBand Plus is a medical device manufactured by International Life Sciences. It received FDA 510(k) clearance on 2023-05-26 under approval number K230316. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FlexBand; FlexPatch; FlexBand Plus?
FlexBand; FlexPatch; FlexBand Plus is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by International Life Sciences. The 510(k) number is K230316.
When was FlexBand; FlexPatch; FlexBand Plus approved by the FDA?
FlexBand; FlexPatch; FlexBand Plus received FDA 510(k) clearance on 2023-05-26, under approval number K230316.
What company makes FlexBand; FlexPatch; FlexBand Plus?
FlexBand; FlexPatch; FlexBand Plus is manufactured by International Life Sciences.
What is the FDA product code for FlexBand; FlexPatch; FlexBand Plus?
The FDA product code for FlexBand; FlexPatch; FlexBand Plus is OWW.
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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.