Miha Bodytec GmbH

FDA Regulatory Profile

Miha Bodytec GmbH has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 17, 2026 · NAI
Latest 510(k)
Oct 7, 2022

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 17, 2026Addison, ILDevicesNo Action Indicated (NAI)3015529344

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
K221498Miha Bodytec IIOct 7, 2022
K201975miha bodytec IIMar 11, 2021
K182519Miha Bodytec IIJun 7, 2019