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 |