ELFCARE DEVICE, MODELS 314A THROUGH 314G


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K023231
Device Name ELFCARE DEVICE, MODELS 314A THROUGH 314G
Original Applicant
MEDISEB LTD.
beit hapa’amon (box 124)
20 hata’as st.
kfar saba,, 

IL

44425

Original Contact ahava stein
Regulation Number 882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ILO   IPF  
Date Received 09/27/2002
Decision Date 04/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No