FD TENS 2050 OR SLIDE TENS MODEL FD2050


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K111645
Device Name FD TENS 2050 OR SLIDE TENS MODEL FD2050
Applicant
FUJI DYNAMICS LTD
unit 1-3, 23/f laws commerical
plaza 788 cheung sha wan rd
hong kong, 

CN

ch

Applicant Contact ching kong (felix) lee
Correspondent
FUJI DYNAMICS LTD
unit 1-3, 23/f laws commerical
plaza 788 cheung sha wan rd
hong kong, 

CN

ch

Correspodent Contact ching kong (felix) lee
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 06/13/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No