510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K871633Substantially Equivalent

Tru-Sound Ultrasound Therapy Unit

Tru-Trac Therapy Products, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871633 is the FDA 510(k) clearance record for TRU-SOUND ULTRASOUND THERAPY UNIT, a class II device, cleared for Tru-Trac Therapy Products, Inc. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Tru-Trac Therapy Products, Inc., from to . As of , FDA records show no recalls naming K871633.

Clearance record

Decision date
Received
(31 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
Tru-Trac Therapy Products, Inc. 27635 Diaz Rd., Temecula CA
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