TONE-A-MATIC INTERNATIONAL, INC.

FDA Device Registration & Listing · MISSISSAUGA Ontario, CA · Registration 3006551156

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
3006551156
FEI Number
3006551156
Entity Name
TONE-A-MATIC INTERNATIONAL, INC.
City/State/Country
MISSISSAUGA Ontario, CA
Establishment Address
145 TRADERS BLVD, EAST,, UNIT 18, MISSISSAUGA Ontario L4Z-3L3, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TONE-A-MATIC INTERNATIONAL, INC. (Owner Number: 9102041)
Owner / Operator Contact Address
145 TRADERS BLVD, EAST,, UNIT 18, MISSISSAUGA,, CA-ON L4Z-3L3, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221724
PMA Number
N/A

All Registered Proprietary Names

TAMTEC-HANA TENS / EMS (SPORT MUSCLE STIMULATOR) TAMTEC TDR 68-4 TAMTEC TDR 68-4 PRO TAMTEC8, TMT580 TONE-A-MATIC TAMTEC Multi-Functional Garment Electrodes Direct Connect Ab & Back Belt, Knee & Elbow Brace TONE-A-MATIC TDR68 TONE-A-MATIC TAMEXX Pad Prolonger Gel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2015-01-27
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2015-01-27
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2007-05-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2023-02-02
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2014-01-28
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2014-01-28
GYB Media, Electroconductive Neurology Class 2 882.1275 2023-01-25

Official Correspondent

EMMANUEL MBULU

US Agent Details

ANNIA KORDIUK Business: TAM INTERNATIONAL Email: toneamaticint@gmail.com Phone: (716) 8520135

Related Public Records

Same Entity

TONE-A-MATIC INTERNATIONAL, 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
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006551156. Last updated year: 2026. Please use registration number 3006551156 when referencing this establishment in official correspondence.
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