510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080970Substantially Equivalent

Ushifu Stepper

Ushifu Development Company, LLC, Deland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080970 is the FDA 510(k) clearance record for USHIFU STEPPER, a class II device, cleared for Ushifu Development Company, LLC on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list one 510(k) clearance for Ushifu Development Company, LLC. As of , FDA records show no recalls naming K080970.

Clearance record

Decision date
Received
(68 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Ushifu Development Company, LLC 1450 S. Woodland Blvd., Deland FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260