COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D


Device Classification Name

device, iontophoresis, other uses

510(k) Number K080580
Device Name COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
Applicant
AXELGAARD MFG. CO., LTD.
520 industrial way
fallbrook, 
CA 
92028 -2244

Applicant Contact dan p jeffery
Correspondent
AXELGAARD MFG. CO., LTD.
520 industrial way
fallbrook, 
CA 
92028 -2244

Correspodent Contact dan p jeffery
Regulation Number 890.5525
Classification Product Code
EGJ  
Date Received 03/03/2008
Decision Date 06/18/2008
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