Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K092476 |
Device Name |
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M |
Applicant |
SPORT-ELEC |
141 RESEARCH DRIVE |
COMPLIANCE DEPT. |
HAMPTON,
VA
23666
|
|
Applicant Contact |
KIMBERLY ROSS |
Correspondent |
SPORT-ELEC |
141 RESEARCH DRIVE |
COMPLIANCE DEPT. |
HAMPTON,
VA
23666
|
|
Correspondent Contact |
KIMBERLY ROSS |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/12/2009 |
Decision Date | 05/07/2010 |
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
|
|
|