SOFT-TOUCH TENS ELECTRODE


Device Classification Name

electrode, cutaneous

510(k) Number K030375
Device Name SOFT-TOUCH TENS ELECTRODE
Applicant
PAIN MANAGEMENT TECHNOLOGIES
43 e. market st.
akron, 
OH 
44308

Applicant Contact joshua lefkovitz
Correspondent
PAIN MANAGEMENT TECHNOLOGIES
43 e. market st.
akron, 
OH 
44308

Correspodent Contact joshua lefkovitz
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 02/04/2003
Decision Date 05/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No