MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000


Device Classification Name

stimulator, electrical, transcutaneous, for arthritis

510(k) Number K030332
Device Name MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
Original Applicant
BIONICARE MEDICAL TECHNOLOGIES, INC.
47 r loveton circle
sparks, 
MD 
21152

Original Contact kent hoffman
Regulation Number 882.5890
Classification Product Code
NYN  
Date Received 01/31/2003
Decision Date 06/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No