Device Classification Name |
stimulator, muscle, powered
|
510(k) Number |
K112348 |
Device Name |
RS-4I MUSCLE STIMULATOR |
Applicant |
RS MEDICAL |
14401 S.E. FIRST ST. |
VANCOUVER,
WA
98684
|
|
Applicant Contact |
PATRICK COUGILL |
Correspondent |
RS MEDICAL |
14401 S.E. FIRST ST. |
VANCOUVER,
WA
98684
|
|
Correspondent Contact |
PATRICK COUGILL |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/16/2011 |
Decision Date | 01/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|