510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040798Substantially Equivalent

Hes Ultrasonic Therapy Appliance

Hwang Sun Enterprise Co., Ltd., Sound Beach NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040798 is the FDA 510(k) clearance record for HES ULTRASONIC THERAPY APPLIANCE, a class II device, cleared for Hwang Sun Enterprise Co., Ltd. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Hwang Sun Enterprise Co., Ltd., from to . As of , FDA records show no recalls naming K040798.

Clearance record

Decision date
Received
(128 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Hwang Sun Enterprise Co., Ltd. 30 Northport Rd., Sound Beach NY
510(k) summary
Statement
Third party review
No

Clearances, product code IMI

Trailing 12 months

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

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