510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K925043Substantially Equivalent

Elbow Cpm Orthosis

Electrobionics Corp., Ankeny IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925043 is the FDA 510(k) clearance record for ELBOW CPM ORTHOSIS, a class I device, cleared for Electrobionics Corp. on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for Electrobionics Corp. As of , FDA records show no recalls naming K925043.

Clearance record

Decision date
Received
(130 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Electrobionics Corp. 2010 S. Ankeny Blvd., Ankeny IA
510(k) summary
Statement
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