510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843493Substantially Equivalent

Patient Guided Knee Exerciser

Richards Medical Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843493 is the FDA 510(k) clearance record for PATIENT GUIDED KNEE EXERCISER, a class I device, cleared for Richards Medical Co., Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list 71 510(k) clearances for Richards Medical Co., Inc., from to . As of , FDA records show no recalls naming K843493.

Clearance record

Decision date
Received
(6 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Richards Medical Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
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