TOTAL QUALITY MEDICAL, INC.

FDA Device Registration & Listing · Kennebunk, ME, US · Registration 3014144799

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
3014144799
FEI Number
3014144799
Entity Name
TOTAL QUALITY MEDICAL, INC.
City/State/Country
Kennebunk, ME, US
Establishment Address
128 YORK ST, Kennebunk, ME 04043, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Total Quality Medical Inc. (Owner Number: 10056321)
Owner / Operator Contact Address
128 York Street, Kennebunk, ME 04043, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161304
PMA Number
N/A

All Registered Proprietary Names

TQE Plus Endotoxin 30" Filter Flat 222 Head TQE Plus Endotoxin 20" Filter Flat 222 Head TQE Plus Endotoxin 10" Filter Flat 222 Head

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2017-11-28

Official Correspondent

Michael Kennedy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Total Quality Medical 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
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

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3003550196 Veolia Water Treatment & Solutions ARLINGTON, TX, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014144799. Last updated year: 2026. Please use registration number 3014144799 when referencing this establishment in official correspondence.
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