FD TENS 2070


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K111654
Device Name FD TENS 2070
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 03/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No