510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K902452Substantially Equivalent

Continuous Passive Motion (Cpm) Leg Exerciser

Berner Assoc., Inc., Golden Valley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902452 is the FDA 510(k) clearance record for CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER, a class I device, cleared for Berner Assoc., Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for Berner Assoc., Inc. As of , FDA records show no recalls naming K902452.

Clearance record

Decision date
Received
(10 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Berner Assoc., Inc. 2525 Nevada Ave. #302, Golden Valley MN
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