MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K022405
Device Name MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
Original Applicant
REHABILICARE, INC.
1811 old highway 8
new brighton, 
MN 
55112

Original Contact edward f valdez
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 07/16/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No