510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934287Substantially Equivalent

Dynasound Model 401 Therapeutic Ultrasound Stimulator

Dynawave, Corp., Geneva IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934287 is the FDA 510(k) clearance record for DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR, a class II device, cleared for Dynawave, Corp. on under FDA product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat). FDA records list 3 510(k) clearances for Dynawave, Corp., from to . As of , FDA records show no recalls naming K934287.

Clearance record

Decision date
Received
(214 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
Dynawave, Corp. 2520 Kaneville Ct., Geneva IL
510(k) summary
Summary
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