510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013328Substantially Equivalent

Remington Paraffin Spa, Models Hs-200. Pfs-600

Remington Products Company LLC, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013328 is the FDA 510(k) clearance record for REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600, a class II device, cleared for Remington Products Company, LLC on under FDA product code IMC (Bath, Paraffin). FDA records list 3 510(k) clearances for Remington Products Company, LLC, from to . As of , FDA records show no recalls naming K013328.

Clearance record

Decision date
Received
(59 days to decision)
Product code
IMC Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Applicant
Remington Products Company, LLC 1400 Sixteenth St., NW, Washington DC
510(k) summary
Summary
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