510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K112520Substantially Equivalent

US-101L, US-103S

Ito Co., Ltd., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112520 is the FDA 510(k) clearance record for US-101L, US-103S, a class II device, cleared for Ito Co., Ltd. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Ito Co., Ltd. As of , FDA records show no recalls naming K112520.

Clearance record

Decision date
Received
(56 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
Ito Co., Ltd. 3-3-3 Toyotama-Minami, Tokyo, JP
510(k) summary
Summary PDF
Third party review
Yes

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