SCRAMBLER ST 5 TENS DEVICE


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K081255
Device Name SCRAMBLER ST 5 TENS DEVICE
Applicant
COMPETITIVE TECHNOLOGIES,INC.
49 plain st.
north attleboro, 
MA 
02760 -2

Applicant Contact mary mcnamara
Correspondent
COMPETITIVE TECHNOLOGIES,INC.
49 plain st.
north attleboro, 
MA 
02760 -2

Correspodent Contact mary mcnamara
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 05/02/2008
Decision Date 02/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No