Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013515165

FEI Number

3013515165

Entity Name

BTT HEALTH GMBH

City/State/Country

Greifenberg Bavaria, DE

Establishment Address

Beurer Str. 25a, Greifenberg Bavaria 86926, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BTT Health GmbH (Owner Number: 10054048)

Owner / Operator Contact Address

Beurer Strasse 25a, Greifenberg, DE-BY 86926, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Marodyne LiV System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2017-02-06

Official Correspondent

Michael Volkmann

US Agent Details

Saulo Waisenbeg Business: COPA HEALTHCARE L.L.C Email: saulo@copahealth.us Phone: (954) 4961622

Related Public Records

Same Entity

BTT Health GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013515165. Last updated year: 2026. Please use registration number 3013515165 when referencing this establishment in official correspondence.