Cleared Traditional

MEDICAL TREATMENT CHAIR, T400, T500,T600

K091727 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · Physical Medicine

Jul 2009

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K091727 is an FDA 510(k) clearance for the MEDICAL TREATMENT CHAIR, T400, T500,T600, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Fresenius Medical Care South Asia Pacific Pty , Ltd. (Milsons Point,, AU). The FDA issued a Cleared decision on July 6, 2009, 25 days after receiving the submission on June 11, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.

Submission Details

510(k) Number	K091727 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2009
Decision Date	July 06, 2009
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF