Device Classification Name |
ultrasonic diathermy for use in applying therapeutic deep heat
|
510(k) Number |
K032793 |
Device Name |
US-100 PORTABLE ULTRASOUND THERAPY UNIT |
Applicant |
ITO CO., LTD. |
2305 GOLD MINE RD. |
BROOKEVILLE,
MD
20833
|
|
Applicant Contact |
T. WHIT ATHEY |
Correspondent |
ITO CO., LTD. |
2305 GOLD MINE RD. |
BROOKEVILLE,
MD
20833
|
|
Correspondent Contact |
T. WHIT ATHEY |
Regulation Number | 890.5300
|
Classification Product Code |
|
Date Received | 09/09/2003 |
Decision Date | 10/09/2003 |
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
|
|
|