Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Miha Bodytec II

K-Number: K221498 · 2022-10-07

ApplicantMiha Bodytec GmbH
Decision Date2022-10-07
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Miha Bodytec II is a medical device manufactured by Miha Bodytec GmbH. It received FDA 510(k) clearance on 2022-10-07 under approval number K221498. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miha Bodytec II?

Miha Bodytec II is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Miha Bodytec GmbH. The 510(k) number is K221498.

When was Miha Bodytec II approved by the FDA?

Miha Bodytec II received FDA 510(k) clearance on 2022-10-07, under approval number K221498.

What company makes Miha Bodytec II?

Miha Bodytec II is manufactured by Miha Bodytec GmbH.

What is the FDA product code for Miha Bodytec II?

The FDA product code for Miha Bodytec II is NGX.

Other Devices by Miha Bodytec GmbH

K182519Miha Bodytec II K201975miha bodytec II

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

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.

↑