510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K001860Substantially Equivalent

Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra

FKA Distributing Co., LLC, Commerce Township MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001860 is the FDA 510(k) clearance record for PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA, a class II device, cleared for Homedics, Inc. on under FDA product code IMC (Bath, Paraffin). FDA records list 2 510(k) clearances for FKA Distributing Co., LLC, from to . As of , FDA records show no recalls naming K001860.

Clearance record

Decision date
Received
(52 days to decision)
Product code
IMC Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Applicant
Homedics, Inc. 3000 Pontiac Trl., Commerce Township MI
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