Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K113037 |
Device Name |
PAIN-AID |
Applicant |
PDI WORKS, LLC. |
2150 SOUTH LEE HIGHWAY |
CLEVELAND,
TN
37311
|
|
Applicant Contact |
THU-HA DUNCAN |
Correspondent |
PDI WORKS, LLC. |
2150 SOUTH LEE HIGHWAY |
CLEVELAND,
TN
37311
|
|
Correspondent Contact |
THU-HA DUNCAN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/2011 |
Decision Date | 03/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|