HUAYI H035 BASIC WHEELCHAIR


Device Classification Name

wheelchair, mechanical

510(k) Number K080114
Device Name HUAYI H035 BASIC WHEELCHAIR
Applicant
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
9109 copenhaver drive
potomac, 
MD 
20854

Applicant Contact norman f estrin
Correspondent
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
9109 copenhaver drive
potomac, 
MD 
20854

Correspodent Contact norman f estrin
Regulation Number 890.3850
Classification Product Code
IOR  
Date Received 01/16/2008
Decision Date 02/15/2008
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