FDA.reportPublic FDA data

510(k) K831889

Device
Surgeon's Choice Crutch Handle
Applicant
W.K. WHEELER, INC.
510(k) number
K831889
Product code
INP
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-07
Date received
1983-06-14
Regulation
890.3790
Classification name
Tips And Pads, Cane, Crutch And Walker
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code INP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831149PERSONAL KNEE CRUTCH PADTecnol New Jersey Wound Care, Inc.1983-05-03
K811493CRUTCH & WALKER PADSFred Sammons, Inc.1981-06-12
K810650CRUTCH TIPS & GRIPSFirst Industries, Inc.1981-03-26
K803136CONPHAR CRUTCH TIPSConphar, Inc.1981-01-08
K803140CONPHAR CRUTCH GRIPSConphar, Inc.1981-01-08
K803144CONPHAR CRUTCH PADSConphar, Inc.1981-01-08
K800076CRUTCH TIPS, PADS & HAND GRIPSNew World Imports, Inc.1980-01-28