LANDLEX, MODEL S300X


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K050792
Device Name LANDLEX, MODEL S300X
Applicant
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
no. 17, 37th rd.
taichung industry park
taichung, 

TW

40768

Applicant Contact chang wan lan
Correspondent
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
no. 17, 37th rd.
taichung industry park
taichung, 

TW

40768

Correspodent Contact chang wan lan
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 03/28/2005
Decision Date 04/21/2005
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