510(k) K770146

Device: SWIVEL HEAD ADJUSTABLE CRUTCH
Applicant: Maddak, Inc.
510(k) number: K770146
Product code: IPR
Decision: Substantially Equivalent (SESE)
Decision date: 1977-01-28
Date received: 1977-01-24
Regulation: 890.3150
Classification name: Crutch
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 1
Clearance type: Traditional
Third party reviewed: N

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 IPR#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K821403	LIGHT WEIGHT ALUMINUM CRUTCHES	Manuco Manufacturing Co., Inc.	1982-06-21
K800237	FOLDING CRUTCH	Husa Folding Crutch Co., Inc.	1980-02-22
K790557	CRUTCH	Maddak, Inc.	1979-04-03