MIHA BODYTEC GMBH

FDA Device Registration & Listing · Gersthofen Bavaria, DE · Registration 3010385841

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010385841
FEI Number
3010385841
Entity Name
MIHA BODYTEC GMBH
City/State/Country
Gersthofen Bavaria, DE
Establishment Address
Siemensstr. 1, Gersthofen Bavaria 86368, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
miha bodytec GmbH (Owner Number: 10044612)
Owner / Operator Contact Address
Siemensstr. 1, Gersthofen, DE-BY 86368, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221498
PMA Number
N/A

All Registered Proprietary Names

i-body connect wireless miha bodytec m.ove miha bodytec II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-04-04
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

Rhonda Alexander Business: IUVO Consulting, LLC Email: ralexander@iuvoconsulting.com Phone: (757) 5824337

Related Public Records

Same Entity

miha bodytec GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010385841. Last updated year: 2026. Please use registration number 3010385841 when referencing this establishment in official correspondence.
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