FDA.reportPublic FDA data

510(k) K821403

Device
LIGHT WEIGHT ALUMINUM CRUTCHES
Applicant
MANUCO MANUFACTURING CO., INC.
510(k) number
K821403
Product code
IPR  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-21
Date received
1982-05-11
Regulation
890.3150
Classification name
Crutch
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IPR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800237FOLDING CRUTCHHusa Folding Crutch Co., Inc.1980-02-22
K790557CRUTCHMaddak, Inc.1979-04-03
K770146SWIVEL HEAD ADJUSTABLE CRUTCHMaddak, Inc.1977-01-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases