Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K133225 |
Device Name |
E-FIT EF-1280 EMS MACHINE |
Applicant |
FIT-PRO KFT LTD. |
144 RESEARCH DRIVE |
HAMPTON,
VA
23666
|
|
Applicant Contact |
RHONDA ALEXANDER, M.S., M.P.A. |
Correspondent |
FIT-PRO KFT LTD. |
144 RESEARCH DRIVE |
HAMPTON,
VA
23666
|
|
Correspondent Contact |
RHONDA ALEXANDER, M.S., M.P.A. |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/21/2013 |
Decision Date | 10/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|