← Back to catalogue

Miha Bodytec II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201975

by Miha Bodytec GmbH

Identifiers

510(k) Number
K201975 FDA 510(k)
FDA Product Code
NGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Miha Bodytec II is an EMS (Electrical Muscle Stimulation) device for professional use, designed for whole-body EMS training in studios, fitness, and therapy settings. It features a robust aluminum casing that protects high-quality electronic components, all manufactured to the highest standards in Germany.

The device is supplied as a medical product and is intended for professional use in continuous daily operation. It is FDA 510(k) cleared with product code NGX and K-number K201975, classified under Physical Medicine. The device is manufactured by Miha Bodytec GmbH in Gersthofen, Germany.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MiHa-GmbH Hannover Startseite, EMS Devices for Professional Use - Made in Germany - miha bodytec II, Medizinische EMS by miha bodytec, miha bodytec - EMS Equipment - Made in Germany

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Miha Bodytec GmbH

Sources (1)

  • FDA 510(k) K201975 24 fields · synced Oct 6, 2026