Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K123158 |
Device Name |
ION MAGNUM GENIUS |
Applicant |
ION GENIUS INC |
7192 KALANIANAOLE HWY |
#D-204A |
HONOLULU,
HI
96821
|
|
Applicant Contact |
XANYA SOFRA-WEISS |
Correspondent |
ION GENIUS INC |
7192 KALANIANAOLE HWY |
#D-204A |
HONOLULU,
HI
96821
|
|
Correspondent Contact |
XANYA SOFRA-WEISS |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 10/09/2012 |
Decision Date | 06/21/2013 |
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
|
|
|