510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202337Substantially Equivalent

Pulsed electromagnetic field wrap

Hi-Dow International Inc., Maryland Heights MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K202337 is the FDA 510(k) clearance record for Pulsed electromagnetic field wrap, a class II device, cleared for Hi-Dow International, Inc. on under FDA product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat). FDA records list 6 510(k) clearances for Hi-Dow International, Inc., from to . As of , FDA records show no recalls naming K202337.

Clearance record

Decision date
Received
(120 days to decision)
Product code
ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Hi-Dow International, Inc. 2555 Metro Blvd., Maryland Heights MO
510(k) summary
Statement
Third party review
No

Clearances, product code ILX

Trailing 12 months

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

FDA records show no clearances under product code ILX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILX, 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