510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962528Substantially Equivalent

Olympus Mobile Chair/couch

KEYMED (Medical & Industrial Equipment) Ltd, Southend-On-Sea, Essex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962528 is the FDA 510(k) clearance record for OLYMPUS MOBILE CHAIR/COUCH, a class I device, cleared for Keymed (Medical & Industrial Equipment), Ltd. on under FDA product code FZK (Chair, Surgical, Non-Electrical). FDA records list 7 510(k) clearances for Keymed (Medical & Industrial Equipment), Ltd., from to . As of , FDA records show no recalls naming K962528.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FZK Chair, Surgical, Non-Electrical
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Keymed (Medical & Industrial Equipment), Ltd. Stock Rd., Southend-On-Sea, Essex, GB
510(k) summary
Statement
Third party review
No

Clearances, product code FZK

Trailing 12 months

FDA records hold no clearances under product code FZK in the trailing twelve months.

FDA records show no clearances under product code FZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZK, 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