The following data is part of a premarket notification filed by Tone-a-matic International, Inc. with the FDA for Tone-a-matic.
| Device ID | K130052 |
| 510k Number | K130052 |
| Device Name: | TONE-A-MATIC |
| Classification | Stimulator, Muscle, Powered |
| Applicant | TONE-A-MATIC INTERNATIONAL, INC. 145 TRADERS BLVD, EAST, UNIT 18 Mississauga, Ontario, CA L4z-3l3 |
| Contact | Annia Kordiuk |
| Correspondent | Annia Kordiuk TONE-A-MATIC INTERNATIONAL, INC. 145 TRADERS BLVD, EAST, UNIT 18 Mississauga, Ontario, CA L4z-3l3 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-09 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TONE-A-MATIC 78202683 3081553 Live/Registered |
1142786 Ontario Inc. 2003-01-13 |
![]() TONE-A-MATIC 73211380 1228208 Dead/Cancelled |
229614 Electronics Limited 1979-04-12 |