FDA 510(k) Application Details - K003048

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K003048
Device Name	Wheelchair, Mechanical
Applicant	ROLL-ABILITY (PTY) LTD. 6162 STEEPLECHASE DR. ROANOKE, VA 24018 US Other 510(k) Applications for this Company
Contact	VICTOR F MYBURGH Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	IOR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2000
Decision Date	12/15/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review