510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931555Substantially Equivalent

Artromot K2 Cpm

Ormed Mfg., Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931555 is the FDA 510(k) clearance record for ARTROMOT K2 CPM, a class I device, cleared for Ormed Mfg., Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list 23 510(k) clearances for Ormed Mfg., Inc., from to . As of , FDA records show no recalls naming K931555.

Clearance record

Decision date
Received
(307 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Ormed Mfg., Inc. 1000 Burnett Ave., Concord CA
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