510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K883914Substantially Equivalent

Fatigmeter

K. Jimbo Co., Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883914 is the FDA 510(k) clearance record for FATIGMETER, a class II device, cleared for K. Jimbo Co., Inc. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list one 510(k) clearance for K. Jimbo Co., Inc. As of , FDA records show no recalls naming K883914.

Clearance record

Decision date
Received
(410 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
K. Jimbo Co., Inc. 6363 Wilshire Blvd., Suite, Los Angeles CA
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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