510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K875381Substantially Equivalent

Ultrasound Diathermy Unit Ultrasound Heater

Ford Laboratories, Inc., Dublin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875381 is the FDA 510(k) clearance record for ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER, a class II device, cleared for Ford Laboratories, Inc. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Ford Laboratories, Inc. As of , FDA records show no recalls naming K875381.

Clearance record

Decision date
Received
(148 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
Ford Laboratories, Inc. 6908 'A' Sierra Ct., Dublin 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