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IMC — Bath, Paraffin Class II

FDA Device Classification

Classification Details

Product Code
IMC
Device Class
Class II
Regulation Number
890.5110
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093100shenzhen comfort technology coREVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)November 24, 2009
K022626raymond industrialMOISTURESTAY (REVLON)October 29, 2002
K013707global tv conceptsSOFTIQUE, MODEL GI 11001February 1, 2002
K013328remington products companyREMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600December 3, 2001
K001860homedicsPARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAAugust 10, 2000
K991427divi intlPARAMED PARAFFIN WARMERAugust 13, 1999
K980718chattanooga groupPARA-CAREMarch 27, 1998
K861344tri w-gR1124 & R1686 PARAFFINMay 27, 1986
K861346tri w-gR1363 PARAFFINMay 2, 1986
K842423grimm scientific industriesPARA THERM BATHJune 28, 1984
K833631bernlit enterprisesTHERMAMED BATHNovember 28, 1983
K770170techhnilab instrumentsMADDATHERM PARAFFIN BATHJanuary 28, 1977