WELL-TENS


codes

Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K002874
Device Name WELL-TENS
Original Applicant
WELL-LIFE CONSULTANT
6co1,no.5.sec.5,hsin yi rd.
taipei, 

TW

Original Contact kevin chiu
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 09/14/2000
Decision Date 07/27/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No