SANIDAD TENS-DUO MODE GP8016N


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K021430
Device Name SANIDAD TENS-DUO MODE GP8016N
Original Applicant
ROLOR ELECTRONICS CORP.
no. 58 fu-chiun st.
hsin-chu city, 

TW

Original Contact ke-min jen
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 05/03/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No