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Higi Sh, LLC

FDA Regulatory Profile

Higi Sh, LLC has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 17, 2017 · NAI
Latest 510(k)
Oct 10, 2017

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 17, 2017Chicago, ILDevicesNo Action Indicated (NAI)3003703880
Sep 4, 2013Chicago, ILDevicesNo Action Indicated (NAI)3003703880

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
K172739higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body…Oct 10, 2017
K151127higi StationDec 8, 2015

FDA data resources