Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K143059 |
Device Name |
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) |
Applicant |
TONE-A-MATIC INTERNATIONAL INC. |
145 TRADERS BLVD EAST, UNIT 18 |
MISSISSAUGA,
CA
L4Z-3L3
|
|
Applicant Contact |
MANUEL CHUCK |
Correspondent |
TONE-A-MATIC INTERNATIONAL INC. |
145 TRADERS BLVD EAST, UNIT 18 |
MISSISSAUGA,
CA
L4Z-3L3
|
|
Correspondent Contact |
MANUEL CHUCK |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/24/2014 |
Decision Date | 01/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|