| Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
| 510(k) Number |
K083140 |
| Device Name |
COMPEX SPORT PLUS |
| Applicant |
| Chattanooga Group |
| 4717 Adams Rd. |
|
Hixson,
TN
37343
|
|
| Applicant Contact |
MICHAEL TREAS |
| Correspondent |
| Chattanooga Group |
| 4717 Adams Rd. |
|
Hixson,
TN
37343
|
|
| Correspondent Contact |
MICHAEL TREAS |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 10/23/2008 |
| Decision Date | 02/09/2009 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|