510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091727Substantially Equivalent

Medical Treatment Chair, T400, T500,t600

Fresenius Medical Care South Asia Pacific Pty, Ltd., Milsons Point,, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091727 is the FDA 510(k) clearance record for MEDICAL TREATMENT CHAIR, T400, T500,T600, a class II device, cleared for Fresenius Medical Care South Asia Pacific Pty , Ltd. on under FDA product code INO (Chair, Positioning, Electric). FDA records list 2 510(k) clearances for Fresenius Medical Care South Asia Pacific Pty , Ltd., from to . As of , FDA records show no recalls naming K091727.

Clearance record

Decision date
Received
(25 days to decision)
Product code
INO Chair, Positioning, Electric
Regulation
21 CFR 890.3110
Device class
Class II
Review panel
Physical Medicine
Applicant
Fresenius Medical Care South Asia Pacific Pty , Ltd. Level 17, 61 Lavender St., Milsons Point,, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INO

Trailing 12 months

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

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