Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K121401 |
Device Name |
TENDER TOUCH |
Applicant |
SOMETECH CORPORATION |
965 Oakland Rd. |
Suite 2B |
Lawrenceville,
GA
30044
|
|
Applicant Contact |
KI HAN |
Correspondent |
SOMETECH CORPORATION |
965 Oakland Rd. |
Suite 2B |
Lawrenceville,
GA
30044
|
|
Correspondent Contact |
KI HAN |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 05/10/2012 |
Decision Date | 05/01/2013 |
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
|
|
|