Device Classification Name |
Massager, Powered Inflatable Tube
|
510(k) Number |
K112441 |
Device Name |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM |
Applicant |
DAESUNG MAREF CO., LTD. |
4568 WEST 1ST STREET |
SUITE 104 |
LOS ANGELES,
CA
90004
|
|
Applicant Contact |
DANIEL NAM |
Correspondent |
DAESUNG MAREF CO., LTD. |
4568 WEST 1ST STREET |
SUITE 104 |
LOS ANGELES,
CA
90004
|
|
Correspondent Contact |
DANIEL NAM |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 08/24/2011 |
Decision Date | 01/17/2012 |
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
|
|
|