FDA.reportPublic FDA data

510(k) K013707

Device
SOFTIQUE, MODEL GI 11001
Applicant
Global TV Concepts, Ltd.
510(k) number
K013707
Product code
IMC
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-01
Date received
2001-11-08
Regulation
890.5110
Classification name
Bath, Paraffin
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LAURIE BRADEN
Address
676 S. Military Trl. Deerfield Beach FL US 33442 33442

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IMC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093100REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)Shenzhen Comfort Technology Co., Ltd.2009-11-24
K022626MOISTURESTAY (REVLON)Raymond Industrial, Ltd.2002-10-29
K013328REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600Remington Products Company, LLC2001-12-03
K001860PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAHomedics, Inc.2000-08-10
K991427PARAMED PARAFFIN WARMERDivi Intl. Co.1999-08-13
K980718PARA-CAREChattanooga Group, Inc.1998-03-27
K861344R1124 & R1686 PARAFFINTri W-G, Inc.1986-05-27
K861346R1363 PARAFFINTri W-G, Inc.1986-05-02
K842423PARA THERM BATHGrimm Scientific Industries, Inc.1984-06-28
K833631THERMAMED BATHBernlit Enterprises, Inc.1983-11-28
K770170MADDATHERM PARAFFIN BATHTechhnilab Instruments, Inc.1977-01-28