510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864766Substantially Equivalent

Soundtek Model Ut-4700

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

K864766 is the FDA 510(k) clearance record for SOUNDTEK MODEL UT-4700, a class II device, cleared for Soundtek, Inc. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Soundtek, Inc. As of , FDA records show no recalls naming K864766.

Clearance record

Decision date
Received
(97 days to decision)
Product code
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Soundtek, Inc. 2520 Kaneville Ct., Geneva IL
Third party review
No

Clearances, product code IMJ

Trailing 12 months
2 clearances under product code IMJ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IMJ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260