HEARTWAY POWER MOBILITY SCOOTER, PF7


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K080242
Device Name HEARTWAY POWER MOBILITY SCOOTER, PF7
Applicant
HEARTWAY MEDICAL PRODUCTS CO., LTD.
no.58, fu-chiun st.
hsin-chu city, 

TW

408

Applicant Contact jen ke-min
Correspondent
HEARTWAY MEDICAL PRODUCTS CO., LTD.
no.58, fu-chiun st.
hsin-chu city, 

TW

408

Correspodent Contact jen ke-min
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 01/31/2008
Decision Date 02/27/2008
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