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Eneura, Inc.

FDA Regulatory Profile

Eneura, Inc. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 11, 2018 · NAI
Latest 510(k)
May 16, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 11, 2018West Palm Beach, FLDevicesNo Action Indicated (NAI)3008487930

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K230358SAVI Dual (TM) Migraine TherapyMay 16, 2023
K182976SpringTMSFeb 25, 2019
K162797SpringTMSJun 26, 2017
K161663sTMS miniAug 23, 2016

FDA data resources