AVACEN, INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3009668937

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
3009668937
FEI Number
3009668937
Entity Name
AVACEN, INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
6451 El Camino Real Ste C, Carlsbad, CA 92009, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AVACEN, Inc. (Owner Number: 10041019)
Owner / Operator Contact Address
6451 El Camino Real, Suite C, Carlsbad, CA 92009, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133981
PMA Number
N/A

All Registered Proprietary Names

AVACEN HOME AVACEN XL AVACEN HOME XL AVACEN 100 AVACEN PRO+ AVACEN GXL AVACEN PRO

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 2014-08-18

Official Correspondent

Thomas Muehlbauer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AVACEN, Inc.
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
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 3009668937. Last updated year: 2026. Please use registration number 3009668937 when referencing this establishment in official correspondence.
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