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510(k) K833631

THERMAMED BATH by Bernlit Enterprises, Inc. — Product Code IMC

K833631 is an FDA 510(k) premarket notification submitted by Bernlit Enterprises, Inc. for the device "THERMAMED BATH". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
October 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Paraffin
Device Class
Class II
Regulation Number
890.5110
Review Panel
PM
Submission Type

Other clearances for product code IMC

  • K093100 — REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) (November 24, 2009)
  • K022626 — MOISTURESTAY (REVLON) (October 29, 2002)
  • K013707 — SOFTIQUE, MODEL GI 11001 (February 1, 2002)
  • K013328 — REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 (December 3, 2001)
  • K001860 — PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA (August 10, 2000)
  • K991427 — PARAMED PARAFFIN WARMER (August 13, 1999)
  • K980718 — PARA-CARE (March 27, 1998)
  • K861344 — R1124 & R1686 PARAFFIN (May 27, 1986)
  • K861346 — R1363 PARAFFIN (May 2, 1986)
  • K842423 — PARA THERM BATH (June 28, 1984)

FDA data resources