Cleared Abbreviated

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

Mar 2006
Decision
39d
Days
Class 2
Risk

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

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on March 7, 2006, 39 days after receiving the submission on January 27, 2006.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3110.

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

Device Classification

Product Code INO - Chair, Positioning, Electric
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3110