510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092780Substantially Equivalent

Inf 4160 Plus, Model D-Fj31f

FUJI Dynamics Limited, Kowloon, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092780 is the FDA 510(k) clearance record for INF 4160 PLUS, MODEL D-FJ31F, a class II device, cleared for Fuji Dynamics Limited on under FDA product code LIH (Interferential Current Therapy). FDA records list 12 510(k) clearances for Fuji Dynamics Limited, from to . As of , FDA records show no recalls naming K092780.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LIH Interferential Current Therapy
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Fuji Dynamics Limited 23/F., Unit 1-3,, Kowloon, Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIH

Trailing 12 months

FDA records hold no clearances under product code LIH in the trailing twelve months.

FDA records show no clearances under product code LIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIH, 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