HIVOX DREAMATE DM-800


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K021952
Device Name HIVOX DREAMATE DM-800
Original Applicant
HIVOX BIOTEK, INC.
no. 58, fu-chiun st.
hsin-chu city, 

TW

Original Contact ke-min jen
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 06/13/2002
Decision Date 05/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No