510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052340Substantially Equivalent

Du857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System

Alfa Tech Medical Systems, Ltd., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052340 is the FDA 510(k) clearance record for DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM, a class II device, cleared for Alfa Tech Medical Systems, Ltd. on under FDA product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Alfa Tech Medical Systems, Ltd., from to . As of , FDA records show no recalls naming K052340.

Clearance record

Decision date
Received
(105 days to decision)
Product code
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5860
Device class
Class II
Review panel
Physical Medicine
Applicant
Alfa Tech Medical Systems, Ltd. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IMG

Trailing 12 months

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

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