510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K930735Substantially Equivalent

Lordex Lumbar Extension Machine

Lordex, Inc., Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930735 is the FDA 510(k) clearance record for LORDEX LUMBAR EXTENSION MACHINE, a class II device, cleared for Lordex, Inc. on under FDA product code ISD (Exerciser, Measuring). FDA records list one 510(k) clearance for Lordex, Inc. As of , FDA records show no recalls naming K930735.

Clearance record

Decision date
Received
(595 days to decision)
Product code
ISD Exerciser, Measuring
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Lordex, Inc. 10044 Adams Ave., Huntington Beach CA
510(k) summary
Summary
Third party review
No

Clearances, product code ISD

Trailing 12 months

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

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