510(k) K780617

Device: Equalizer
Applicant: BALLERT ORTHOPEDIC CORP.
510(k) number: K780617
Product code: IPG
Decision: Substantially Equivalent (SESE)
Decision date: 1978-04-18
Date received: 1978-04-13
Regulation: 890.3025
Classification name: Shoe, Cast
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 IPG#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K024279	NESS CHILDREN SYSTEM	Ness-Neuromuscular Electrical Stimulation Systems	2003-02-05
K790652	TOGUARD	Togard, Inc.	1979-04-04
K781363	CAST SHOE	Cutler Biomedical	1978-08-14
K760575	ROCKER-SOLE CAST SANDAL	Richard'S Medical Equip., Inc.	1976-10-06
K760578	BALANCED CAST SOLE	Parke-Davis Co.	1976-09-27