510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833631Substantially Equivalent

Thermamed Bath

Bernlit Enterprises, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833631 is the FDA 510(k) clearance record for THERMAMED BATH, a class II device, cleared for Bernlit Enterprises, Inc. on under FDA product code IMC (Bath, Paraffin). FDA records list one 510(k) clearance for Bernlit Enterprises, Inc. As of , FDA records show no recalls naming K833631.

Clearance record

Decision date
Received
(42 days to decision)
Product code
IMC Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Applicant
Bernlit Enterprises, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code IMC

Trailing 12 months

FDA records hold no clearances under product code IMC in the trailing twelve months.

FDA records show no clearances under product code IMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260