Cleared Traditional

K112944 - FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES

K112944 is an FDA 510(k) clearance for FRESENIUS MEDICAL TREATMENT CHAIR T688 ..., manufactured by Fresenius Medical Care South Asia Pacific Pty , Ltd.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K112944 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
87d
Days
Class 2
Risk

K112944 is an FDA 510(k) clearance for the FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Fresenius Medical Care South Asia Pacific Pty , Ltd. (Milsons Point,, AU). The FDA issued a Cleared decision on December 30, 2011 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112944

510(k) Number K112944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date December 30, 2011
Days to Decision 87 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 116d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 35
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K112944 · FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
Download PDF FDA Summary Fresenius Medical Car…