MIBETEC U.S.

FDA Device Registration & Listing · Sugar Land, TX, US · Registration 3015633277

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
3015633277
FEI Number
3015633277
Entity Name
MIBETEC U.S.
City/State/Country
Sugar Land, TX, US
Establishment Address
5826 New Territory Boulevard, Suite #1039, Sugar Land, TX 77479, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
MibeTec GmbH (Owner Number: 10060938)
Owner / Operator Contact Address
Munchener Strasse 15, Sandersdorf-Brehna, DE-ST 06796, DE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K160943
PMA Number
N/A

All Registered Proprietary Names

Bite Away

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2019-07-17

Official Correspondent

Kenneth Kleinhenz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015733772 MIBETEC GMBH Sandersdorf-Brehna Saxony-Anhalt, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015633277. Last updated year: 2026. Please use registration number 3015633277 when referencing this establishment in official correspondence.
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