Data / Medical devices / Canada / Tone-A-Matic International, Inc.
Tone-A-Matic International, Inc.: FDA-registered device maker in MISSISSAUGA Ontario, Canada, 5 510(k) clearances
Tone-A-Matic International, Inc. is registered with the FDA (registration 3006551156) in MISSISSAUGA Ontario, Canada. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 1, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006551156
- Address
- 145 Traders BLVD, East, Unit 18, MISSISSAUGA Ontario, Canada, L4Z-3L3
- Owner or operator
- TONE-A-MATIC INTERNATIONAL, INC. (9102041)
- Roles
- Manufacturer
- First device listed
- May 24, 2007
- Registered through
- 2026
- Brand names listed
- TAMTEC TDR 68-4, TAMTEC TDR 68-4 PRO, TAMTEC-HANA TENS / EMS (SPORT MUSCLE STIMULATOR), TAMTEC8, TMT580, TONE-A-MATIC TAMEXX Pad Prolonger Gel, TONE-A-MATIC TAMTEC Multi-Functional Garment Electrodes Direct Connect Ab & Back Belt, Knee & Elbow Brace, TONE-A-MATIC TDR68
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 1, 2023 | K222863 | Garment Electrodes | GXY | Substantially Equivalent | Tone-A-Matic International, Inc. | accessdata.fda.gov |
| September 23, 2022 | K221724 | Conductive Gel | GYB | Substantially Equivalent | Tone-A-Matic International, Inc. | accessdata.fda.gov |
| January 26, 2015 | K143059 | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) | NGX | Substantially Equivalent | Tone-A-Matic International, Inc. | accessdata.fda.gov |
| December 20, 2013 | K130052 | TONE-A-MATIC | IPF | Substantially Equivalent | Tone-A-Matic International, Inc. | accessdata.fda.gov |
| November 25, 1983 | K832976 | BX-600 EMS | IPF | Substantially Equivalent | Bloomex International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
Updated February 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.