IMC · Class II · 21 CFR 890.5110

FDA Product Code IMC: Bath, Paraffin

Leading manufacturers include Tri W-G, Inc., Shenzhen Comfort Technology Co., Ltd. and Chattanooga Group, Inc..

12
Total
12
Cleared
50d
Avg days
1977
Since

FDA 510(k) Cleared Bath, Paraffin Devices (Product Code IMC)

12 devices
1–12 of 12
Cleared Nov 24, 2009
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
K093100
Shenzhen Comfort Technology Co., Ltd.
Physical Medicine · 54d
Cleared Aug 13, 1999
PARAMED PARAFFIN WARMER
K991427
Divi Intl. Co.
Physical Medicine · 112d
Cleared Mar 27, 1998
PARA-CARE
K980718
Chattanooga Group, Inc.
Physical Medicine · 31d
Cleared May 27, 1986
R1124 & R1686 PARAFFIN
K861344
Tri W-G, Inc.
Physical Medicine · 50d
Cleared May 02, 1986
R1363 PARAFFIN
K861346
Tri W-G, Inc.
Physical Medicine · 25d

About Product Code IMC - Regulatory Context