510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061443Substantially Equivalent

Smart Usblite, Model M011120

Intelligent Hearing Systems Corp., Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061443 is the FDA 510(k) clearance record for SMART USBLITE, MODEL M011120, a class II device, cleared for Intelligent Hearing Systems on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 13 510(k) clearances for Intelligent Hearing Systems, from to . As of , FDA records show no recalls naming K061443.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Intelligent Hearing Systems 6860 SW 81st St., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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