The following data is part of a premarket notification filed by Tone-a-matic International Inc. with the FDA for Tamtec-hana Tens / Ems (sport Muscle Stimulator).
| Device ID | K143059 |
| 510k Number | K143059 |
| Device Name: | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | TONE-A-MATIC INTERNATIONAL INC. 145 TRADERS BLVD EAST, UNIT 18 Mississauga, CA L4z-3l3 |
| Contact | Manuel Chuck |
| Correspondent | Manuel Chuck TONE-A-MATIC INTERNATIONAL INC. 145 TRADERS BLVD EAST, UNIT 18 Mississauga, CA L4z-3l3 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-24 |
| Decision Date | 2015-01-26 |