Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K051680 |
Device Name |
DYNATRON DX2 TRACTION UNIT |
Applicant |
DYNATRONICS CORP. |
7030 PARK CENTRE DR. |
SALT LAKE CITY,
UT
84121
|
|
Applicant Contact |
RON HATCH |
Correspondent |
DYNATRONICS CORP. |
7030 PARK CENTRE DR. |
SALT LAKE CITY,
UT
84121
|
|
Correspondent Contact |
RON HATCH |
Regulation Number | 890.5500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/2005 |
Decision Date | 10/11/2005 |
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
|
|
|