Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K132179 |
Device Name |
ARASYS |
Applicant |
ION GENIUS INC |
1833 KALAKAUA AVE. |
HONOLULU,
HI
96801
|
|
Applicant Contact |
XANYA SOFRA-WEISS, PH.D |
Correspondent |
ION GENIUS INC |
1833 KALAKAUA AVE. |
HONOLULU,
HI
96801
|
|
Correspondent Contact |
XANYA SOFRA-WEISS, PH.D |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/15/2013 |
Decision Date | 04/28/2014 |
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
|
|
|