510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945257Substantially Equivalent

577Es (Ergosense)

Lumex, Inc., Bay Shore NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945257 is the FDA 510(k) clearance record for 577ES (ERGOSENSE), a class II device, cleared for Lumex, Inc. on under FDA product code INO (Chair, Positioning, Electric). FDA records list 8 510(k) clearances for Lumex, Inc., from to . As of , FDA records show no recalls naming K945257.

Clearance record

Decision date
Received
(180 days to decision)
Product code
INO Chair, Positioning, Electric
Regulation
21 CFR 890.3110
Device class
Class II
Review panel
Physical Medicine
Applicant
Lumex, Inc. 100 Spence St., Bay Shore NY
510(k) summary
Summary
Third party review
No

Clearances, product code INO

Trailing 12 months

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

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