Cleared Abbreviated

K060212 - MERITS MODEL E SERIES LIFT CHAIRS (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K060212 · Merits Health Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
39d
Days
Class 2
Risk

K060212 is an FDA 510(k) clearance for the MERITS MODEL E SERIES LIFT CHAIRS. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on March 7, 2006 after a review of 39 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merits Health Products Co., Ltd. devices

Submission Details

510(k) Number K060212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2006
Decision Date March 07, 2006
Days to Decision 39 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.