Device Classification Name |
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
|
510(k) Number |
K031077 |
Device Name |
VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM |
Applicant |
CHATTANOOGA GROUP |
4717 ADAMS RD. |
HIXSON,
TN
37343
|
|
Applicant Contact |
CHERYL L BAGWELL |
Correspondent |
CHATTANOOGA GROUP |
4717 ADAMS RD. |
HIXSON,
TN
37343
|
|
Correspondent Contact |
CHERYL L BAGWELL |
Regulation Number | 890.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/04/2003 |
Decision Date | 12/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|