PAIN-AID


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

Correspodent Contact thu-ha duncan
Regulation Number 882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
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