510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953456Substantially Equivalent

E-Z Flex

Fluid Motion Biotechnologies, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953456 is the FDA 510(k) clearance record for E-Z FLEX, a class I device, cleared for Fluid Motion Biotechnologies, Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for Fluid Motion Biotechnologies, Inc. As of , FDA records show no recalls naming K953456.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Fluid Motion Biotechnologies, Inc. 55 Norther Blvd. Suite 410, Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code BXB

Trailing 12 months

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

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