510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961593Substantially Equivalent

Intrastar Pre-Wired Faceplate for in-the-Ear Hearing Aids

Segi Hearing Aid Co., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961593 is the FDA 510(k) clearance record for INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS, a class I device, cleared for Segi Hearing Aid Co. on under FDA product code LRB (Face Plate Hearing Aid). FDA records list one 510(k) clearance for Segi Hearing Aid Co. As of , FDA records show no recalls naming K961593.

Clearance record

Decision date
Received
(197 days to decision)
Product code
LRB Face Plate Hearing Aid
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Segi Hearing Aid Co. 24 Fifth Ave., New York NY
510(k) summary
Summary
Third party review
No

Clearances, product code LRB

Trailing 12 months

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

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