Cleared Traditional

CHAIR, ADJUSTABLE, MECHANICAL

K812399 · Kaye Products, Inc. · Physical Medicine
Sep 1981
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K812399 is an FDA 510(k) clearance for the CHAIR, ADJUSTABLE, MECHANICAL, a Chair, Adjustable, Mechanical (Class I — General Controls, product code INN), submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 25 days after receiving the submission on August 20, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K812399 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1981
Decision Date September 14, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code INN — Chair, Adjustable, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100

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