Device Classification Name |
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
|
510(k) Number |
K083433 |
Device Name |
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 |
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 | 890.5290
|
Classification Product Code |
|
Date Received | 11/20/2008 |
Decision Date | 03/18/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|