TTECH MODEL 200E + TENS DEVICE


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K021436
Device Name TTECH MODEL 200E + TENS DEVICE
Original Applicant
THERATECH, INC.
55 northern blvd., suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 05/06/2002
Decision Date 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No