ZIP’R PC


Device Classification Name

wheelchair, powered

510(k) Number K072224
Device Name ZIP’R PC
Applicant
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
14f-2, no.1 lane 25
zhuangjing road
banqiao, taipei county, 

TW

220

Applicant Contact junnata chang
Correspondent
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
14f-2, no.1 lane 25
zhuangjing road
banqiao, taipei county, 

TW

220

Correspodent Contact junnata chang
Regulation Number 890.3860
Classification Product Code
ITI  
Date Received 08/10/2007
Decision Date 09/21/2007
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