TENSCARE ULTIMA NMS/EMS


Device Classification Name

stimulator, muscle, powered

510(k) Number K023997
Device Name TENSCARE ULTIMA NMS/EMS
Original Applicant
TENSCARE LTD.
76 stockport road
timperley, cheshire, 

GB

wa15 7sn

Original Contact bernard j tremaine
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received 12/03/2002
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No