Device Classification Name |
Stimulator, Muscle, Powered
|
510(k) Number |
K050847 |
Device Name |
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A |
Applicant |
THERATECH, INC. |
1109 MYATT BLVD. |
MADISON,
TN
37115
|
|
Applicant Contact |
MICHAEL PRICE |
Correspondent |
THERATECH, INC. |
1109 MYATT BLVD. |
MADISON,
TN
37115
|
|
Correspondent Contact |
MICHAEL PRICE |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 04/04/2005 |
Decision Date | 06/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|