510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K903851Substantially Equivalent

Club Foot Cpm Machine

Smith & Nephew Richards, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903851 is the FDA 510(k) clearance record for CLUB FOOT CPM MACHINE, a class I device, cleared for Smith & Nephew Richards, Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K903851.

Clearance record

Decision date
Received
(59 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Smith & Nephew Richards, Inc. 1450 Brooks Rd., Memphis TN
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260