510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881211Substantially Equivalent

Tru-Tech 310 Ultrasound Therapy Unit #310

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

K881211 is the FDA 510(k) clearance record for TRU-TECH 310 ULTRASOUND THERAPY UNIT #310, a class II device, cleared for Tru-Trac Therapy Products, Inc. on under FDA product code IMI (Ultrasonic Diathermy 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 K881211.

Clearance record

Decision date
Received
(51 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
Tru-Trac Therapy Products, Inc. 27635 Diaz Rd., Temecula CA
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