FDA 510(k) Application Details - K100327

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K100327
Device Name	Wheelchair, Powered
Applicant	HEARTWAY MEDICAL PRODUCTS CO., LTD. ROC CHINESE- EUROPEAN IND. NO.58, FU-CHUIN STREET HSIN CHU CITY,,, TW HSQ 30067 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen Other 510(k) Applications for this Contact
Regulation Number	890.3860   More FDA Info for this Regulation Number
Classification Product Code	ITI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2010
Decision Date	03/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review